Evonik, one of the world’s leading specialty chemicals companies, stands for appealing business and innovative strength. We work in a trustful and performance-oriented corporate culture that is geared to profitable growth and increasing the value of the company. In more than 100 countries, we benefit from our proximity to customers, and our leading market positions. More than 33,000 employees are bound by a claim: No product is so perfect that it couldn’t be made better. We don’t produce car tires, mattresses, tablets, or animal feed. However, these end products contain Evonik products - like 4,000 others, too. Often, it’s just a small amount that we contribute, but that’s exactly what makes the difference. This is how Evonik makes tires more fuel-efficient, mattresses bouncier, tablets more effective, and animal nutrition healthier. That’s specialty chemicals. And we are one of the best in the world. VACANCY REFERENCE NUMBER: R31361 Project Manager (m/f/div) Biopharma Location: Germany, Darmstadt Management and support of innovation and customer projects in the field of cell culture for new cell culture media components and applications Interdisciplinary collaboration, observation and analysis of technical developments in the field of cell culture media, especially in the biopharmaceutical context, including scientific advice on product-specific topics Independent organization and execution of laboratory tests, including guidance of technicians, documentation and presentation of results as well as preparation of publications and marketing material Technical support for sales in customer meetings and project acquisition Assisting with patent applications and preparing scientific documents Writing and reviewing work instructions and safety documents Completed studies in biotechnology, biochemistry or a similar field, doctorate preferred Professional experience in cell culture process development and project management, ideally in an international context with experience in analytics, data management and statistical methods Profound knowledge of cell culture, metabolism and biopharmaceutical processes, especially CHO cells Understanding of relevant laws and safety regulations as well as experience in handling GMOs Excellent communication skills in German and English as well as a professional demeanor Innovative spirit and independent, structured way of working Discover a world full of possibilities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable. At Evonik, you have the chance to develop and grow together with more than 33,000 colleagues. In addition to attractive career paths and high-quality development programs, we offer performance-based compensation, health promotion measures and hybrid and flexible working models with #SmartWork. Get involved, develop your strengths, break new ground and find a job with us that suits you. Find out more about Evonik directly from our employees: https://careers.evonik.com/en/about/meet-the-team/
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Darmstadt
Über die TU DarmstadtDie TU Darmstadt steht für exzellente und relevante Wissenschaft. Die tiefgreifenden globalen Veränderungsprozesse – von Energiewende bis zu Künstlicher Intelligenz – gestalten wir durch herausragende Forschung und zukunftsweisende Studienangebote entscheidend mit. Zudem zählen wir zu den größten ausbildenden Institutionen in Südhessen; unser Angebot umfasst rund zwanzig Ausbildungsberufe und duale Studiengänge in mehreren Branchen. Als eine in der Metropolregion Frankfurt-Rhein-Main verankerte und sehr stark international geprägte Universität sehen wir uns den europäischen Werten und der europäischen Integration verpflichtet.
Über unseren BereichDie Universitäts- und Landesbibliothek (ULB) ist die zentrale Bibliothek der Technischen Universität Darmstadt. Als wissenschaftliche Universalbibliothek ist sie für die Informationsversorgung für die Bevölkerung Darmstadts und Südhessens sowie für die hier angesiedelten Ausbildungs- und Forschungseinrichtungen, Behörden, Kulturinstitutionen und Betriebe zuständig. Ihre Sammelschwerpunkte sind naturwissenschaftlich-technische Werke sowie geistes- und gesellschaftswissenschaftliche und landeskundliche Literatur. Sie entwickelt und betreibt verschiedene Dienste im Bereich der semantischen Dokumentation von Forschungsdaten und der Digitalisierung und betreut elektronische Publikationen im Open Access.
Ihre AufgabenWir suchen Nachwuchswissenschaftler:innen , die in Ihrem Studium Freude am Recherchieren von wissenschaftlicher Literatur und der Arbeit mit Daten gefunden haben, die teamorientiert denken und ihre Erfahrungen in diesen Feldern ausbauen möchten.
Wir machen Sie fit im Forschungsdatenmanagement, in rechtlichen und technischen Fragen der Bereitstellung von digitalen Medien und im digitalen Publizieren. Sie lernen neueste Techniken des Information Retrieval und der Literaturauswertung mit Methoden des Text- und Datamining kennen.
Eingebunden in verschiedene Arbeitsgruppen sammeln Sie eigene Erfahrungen im Anleiten und Führen von Menschen. Mit diesen Kenntnissen und Ihrem Fachstudium werden Sie eine kompetente Ansprechperson für Wissenschaft und Forschung mit Schnittstellenfunktion in Bibliotheken und Informationszentren.
Die Einstellung erfolgt im Rahmen des Vorbereitungsdienstes an wissenschaftlichen Bibliotheken des Landes Hessen ( Bibliotheksreferendariat ) und einem Beamtenverhältnis auf Widerruf für 2 Jahre. Sie endet mit einer Masterprüfung und der Laufbahnbefähigung für den Höheren Dienst. Diese ist Voraussetzung für Leitungs- und Führungsaufgaben in wissenschaftsnahen Informationseinrichtungen.
Das Referendariat umfasst neben dem Praxisanteil an der Ausbildungsbibliothek auch theoretische Ausbildungsanteile, die als Fernstudienmodule an der Humboldt Universität Berlin absolviert werden. Nähere Informationen hierzu finden Sie unter https://www.hebis.de/aus-und-fortbildung/ausbildung/.
Ihr ProfilBewerberinnen und Bewerber müssen ein Studium vorzugsweise der Biologie, Chemie, Geowissenschaften, Ökologie/Umwelttechnik oder Pharmazie an einer Universität durch Prüfung (Master oder gleichwertiger Abschluss) abgeschlossen haben.
Sie verfügen über diese aufgabenbezogenen Kompetenzen:
• Erste Erfahrungen im Umgang mit Forschungsdaten, Publikationen, Open Science
• Interdisziplinärer fachlicher Horizont
• Erfahrungen im Bibliotheks- und Informationswesen, im Bereich der Drittmittelakquise oder im Projektmanagement sind von Vorteil
• Sehr gute Englischkenntnisse in Wort und Schrift
Sie bringen diese persönlichen Kompetenzen mit:
• Soziale Kompetenzen (insbes. Teamfähigkeit und Kommunikationsfähigkeit)
• Organisationsgeschick
• Fähigkeit zu einem kollegialen Führungsstil
• Ausgeprägtes Servicedenken
Sie müssen darüber hinaus die Voraussetzung zur Einstellung als Beamtin/Beamter erfüllen und dürfen bei Einstellung höchstens 40 Jahre alt sein.
Wir bietenDie Technische Universität Darmstadt bietet
• Einen krisensicheren Ausbildungsplatz
• Eine Ausbildung im wissenschaftlichen Umfeld, mit Kontakt zu Wissenschaftler:innen, Studierenden und Kolleg:innen aus der ganzen Welt
• Einen Ausbildungsbetrieb, bei dem Themen, wie Nachhaltigkeit, Weltoffenheit und Respekt voreinander gelebt werden
• Vermögenswirksame Leistungen
• 30 Tage Erholungsurlaub im Jahr
• Flexible Arbeitszeit und mobiles Arbeiten möglich
• Freifahrtberechtigung im gesamten Regionalverkehr in Hessen durch das LandesTicket Hessen
• Kostengünstige Parkmöglichkeiten am Arbeitsort
• Ein umfassendes internes Weiterbildungsangebot
• Fit und Gesund - kostenlose medizinische Vorsorgeuntersuchungen und umfangreiches vergünstigtes Sportangebot
• Vielfältiges Essensangebot auf dem Campus der TU Darmstadt
Allgemeine Hinweise / DatenschutzDie Technische Universität Darmstadt strebt eine Erhöhung des Anteils der Frauen am Personal an und fordert deshalb besonders Frauen auf, sich zu bewerben. Bewerber:innen mit einem Grad der Behinderung von mindestens 50 oder diesen Gleichgestellte werden bei gleicher Eignung bevorzugt.
Mit dem Absenden Ihrer Bewerbung willigen Sie ein, dass Ihre Daten zum Zwecke des Stellenbesetzungsverfahrens gespeichert und verarbeitet werden. Sie finden unsere Datenschutzerklärung auf unserer Homepage.
AnsprechpersonFür Rückfragen stehen wir Ihnen unter [email protected] gerne zur Verfügung.
Bewerbungs- oder Reisekosten können nicht übernommen werden.
Darmstadt
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
A great opportunity has opened within the Data Monitoring, Management and Innovation department to further strengthen our Clinical Data Management team. As an Associate Director Clinical Data Manager, you will play a crucial role in managing and overseeing clinical data management activities within the organization. You will be responsible for ensuring the integrity, accuracy, and completeness of clinical trial data, while also coordinating a team of clinical data management professionals in a matrix setting.
Your role
- Accountable for all Clinical Data Management (CDM) related deliverables in assigned global (Phase I-IIIb) trials or programs of varying complexity
- Provide CDM leadership for assigned trial(s)/program(s), take global accountability and serve as the CDM representative at the study/program level
- Demonstrate project management and operational expertise in the strategic planning and delivery of CDM deliverables at study/program level, e.g. planning timelines and resources, risk identification and management, status tracking, internal and external stakeholder management etc
- Define and execute risk-based data collection, cleaning and quality assurance strategies for eCRF and external data (including coding)
- Ensure the accuracy, integrity, and completeness of clinical trial data through comprehensive data review and validation activities
- Ensure quality of clinical database/deliverables (incl. eCRF and external data) as well as submission readiness of the clinical data management deliverables and data packages (e.g. CDISC)
- Act as primary point of contact within CDM for any HA submission related activities (e.g. preparation of briefing books, attending HA meetings as requested)
- Manage and oversee CRO and vendor performance, including participation in selection/assessment and budget management as required, for assigned trial(s)
- Contribute to the development and maintenance of data management SOPs, work instructions, and best practices.
- Lead process improvement initiatives and drive innovation in the field of Clinical Data Management
- Additionally, if assigned to a program:
- Demonstrate good understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned studies in an assigned program/indication e.g. ensuring consistency across data quality plans
- Utilise understanding of CDASH and SDTM, or other recognised industry standards, to ensure consistency of implementation across studies in assigned program/indication
- May act as a mentor for CDM colleagues within/beyond assigned program
- Demonstrate willingness to take on and lead any program level activity in support of study delivery
Who you are
- Bachelor's or Master's degree in a scientific or technical discipline, preferably in life sciences, data management, or a related field
- Minimum of 10 years of experience in clinical data management within the pharmaceutical, biotechnology, or healthcare industry
- Profound, long-standing experience in leading clinical data management activities in complex Oncology development projects (including large phase III trials) both on trial and program level
- Experience in working in different sourcing models with a focus on in-house models
- Committed to continuous personal and professional development, and bringing external insights to the role to drive innovation and process improvement
- Proficient in contributing to non-study related initiatives e.g. process improvements, in addition to study assignm ents
- Strong project management, analytical, communication, collaboration, and problem-solving skills
- Ability to work proactively and independently on assigned tasks or projects of varying complexity; prioritising and managing multiple activities simultaneously
- Demonstrated ability to lead and oversee end-to-end data management activities within a clinical trial, as well as leading and coordinating global teams in a matrix organization
- Familiar with autonomously providing reports to senior management, including updates on financials, forecasts and timelines
- Proficiency in data management systems and tools, including strong knowledge of regulatory requirements, industry standards, and best practices related to clinical data management
- Experience in Risk Based Data Monitoring/Management, and with clinical trial data standards, such as CDISC, is preferred
What we offer:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
Darmstadt
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your role
In Healthcare Research & Development Quality and Risk Management (RDQRM), we are looking for a dynamic and experienced Senior Project Manager. This role supports the RDQRM Leadership Team (LT) in driving strategic initiatives, managing key projects, and enhancing operational efficiency across the organization. This role requires a proactive leader with exceptional organizational, communication, prioritization and problem-solving skills, as well as excellent stakeholder management capabilities. Your key responsibilities would be to assist the RDQRM Head and executive team in developing and implementing strategic plans and initiatives; manage and prioritize the LT’s schedule, ensuring effective time management and alignment with organizational goals; lead and oversee the RDQRM organizational changes; be responsible for RDQRM communication strategy and related execution; prepare and analyze reports, presentations, and communications for internal and external stakeholders; act as a liaison between the RDQRM LT and various departments, ensuring alignment and effective execution of strategies; oversee special projects and initiatives as directed by the RDQRM Head or LT; foster a positive organizational culture and support employee engagement initiatives; provide leadership and guidance to staff members on various operational and strategic matters.
Who you are
- Ideally, a degree in Life Sciences (Biology, Chemistry, Pharmacy, etc.), equivalent related professional experience may be considered.
- 8+ years in project management within pharmaceutical industry or CROs, with 5+ years of experience leading cross-functional projects with proven implementation skills.
- Project Management Certification, an MBA, Six Sigma Certification is a plus.
- Deep understanding of drug development process and pharmaceutical industry and demonstrated success in working in a global and multi-cultural environment.
- Knowledge of global regulatory GXP requirements with focus on GLP, GCP, GVP.
- Strong understanding of Operational Excellence principles.
- Demonstrated leadership in change management.
- Able to successfully navigate within varying degrees of ambiguity in a fast-paced environment.
- Strong mature leadership, negotiation and influencing skills.
- Fluent in English with excellent writing skills.
What we offer:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
Darmstadt
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your role:
As the Head of Central Quality Systems, you will play a pivotal role in shaping the strategic direction of global quality systems within our organization. Your leadership will ensure compliance, efficiency, and continuous improvement of regulated GxP processes. You will establish and nurture strategic partnerships with key business leaders to align quality systems with overarching business objectives. Driving process standardization and regulatory compliance will be at the forefront of your responsibilities. You will lead a dedicated team of quality experts, guiding them in the development and implementation of comprehensive strategies for global regulated processes. Your data-driven decision-making will facilitate the identification of opportunities for quality enhancements. Additionally, you will oversee complex RDQRM projects and manage a comprehensive communication strategy. By ensuring the integrity and effectiveness of our global quality systems, you will reinforce operational excellence and foster a robust culture of compliance. This is an exceptional opportunity to make a significant impact on our organization’s quality landscape.
Who you are:
- You hold an advanced degree (PhD or MSc) in Life Sciences (e.g., Biology, Chemistry, Pharmacy) or possess equivalent professional experience.
- You have over 10 years of experience as a strategic leader in the international Pharmaceutical/Biopharmaceutical sector, focusing on quality management systems and processes.
- You possess in-depth knowledge of GxP areas, particularly GCP, GVP, and GLP, along with a comprehensive understanding of global regulatory requirements like ICH.
- You have demonstrated success in managing complex projects and leading change management initiatives in a global, multicultural environment.
- You are fluent in English and possess strong communication skills, both written and verbal.
- You have proven people leadership skills, with the ability to engage and influence stakeholders at all organizational levels.
- You are experienced in regulatory inspections and audits, and you understand the nuances of pharmaceutical drug development.
- You are equipped with continuous improvement knowledge and familiarity with tools such as Lean, Six Sigma, and Business Process Management.
What we offer:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
Darmstadt
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your role:
Join our team and take part in delivering cutting-edge statistical input and Real World Data (RWD) analyses essential for driving clinical development, regulatory compliance, and pharmacovigilance initiatives. Your role will involve architecting, designing, and scaling data analytics solutions, predictive modeling, data science, mining, visualization, and implementing algorithms.
You will be instrumental in writing statistical sections of study protocols, collaborating closely with study teams, and effectively communicating results to relevant stakeholders. Your expertise will also extend to articulating, refining, and defending data analytics standards while applying advanced analytics techniques. This may entail processing large datasets, scaling algorithms, or creating user-friendly application interfaces.
In addition to meeting timelines and maintaining high-quality deliverables in line with company and international standards, you will provide invaluable RWD/RWE advice to both internal and external stakeholders.
If you're passionate about RWD/RWE and novel methods to drive informed decision-making and thrive in a dynamic, collaborative environment, we invite you to join us in shaping the future of healthcare.
Who you are:
- Background in health and life sciences (biostatistics, epidemiology), or quantitative data sciences
- Doctoral and/or master’s degree (e.g., PhD, MSc) in Biostatistics, Epidemiology, Mathematics or related field
- Extensive prior experience with RWD/RWE required - Prior experience in the pharmaceutical industry required (4-8 years)
- Demonstrable experience in writing and implementing statistical analysis plans for studies required
- Demonstrable experience in processing large real-world datasets for analyses and studies required
- Experience in predictive modeling, machine learning and artifical intelligence methodology a plus
- Experience in coding (r) a plus
- Excellent oral and written communication skills and demonstrated ability to engage and communicate scientific evidence to peers
- Collaborative, proactive working style, with ability to work independently.
What we offer:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
Darmstadt
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your role
For our preclinical safety group, we are looking for an engaged and enthusiastic Laboratory Head. As Laboratory Head of our preclinicalIn Vivoteam in Darmstadt and study director you will plan, conduct, and evaluate preclinical safety studies according to the agreed timelines in line with our 4R Animal Welfare strategy and GLP requirements. Furthermore, you will implement new preclinical methodology to support our preclinical safety strategy. Fulfilling this task, you will lead a team of currently 8 technicians, and you will be in close collaboration with internal and external partners. You will have the chance to work in international discovery project teams as preclinical safety expert. In addition, you will have the possibility for a certified specialization in pharmacology and toxicology or laboratory animal science.
Who you are
- PhD, Master or equivalent in relevant life science (e.g. veterinarian, biologist, toxicologist, laboratory animal science)
- Experience in toxicology and familiarity with conducting and interpreting toxicological studies under GLP are favorable
- You should have a strong interest in animal welfare of laboratory animals
- Intensive work with rats will be a substantial part of the work
- We expect innovative thinking and collaboration skills
- Experience in managing scientific projects and the ability to work in a result-driven environment as well as in a diverse team
- You have a deep understanding of biology, pharmacology, toxicology and medicine
- You have a good understanding of statistical methods and standard IT applications
- You have good verbal and written communication skills in German and English
What we offer:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
Darmstadt
.
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Your role:
As the Head of Central Quality Systems, you will play a pivotal role in shaping the strategic direction of global quality systems within our organization. Your leadership will ensure compliance, efficiency, and continuous improvement of regulated GxP processes. You will establish and nurture strategic partnerships with key business leaders to align quality systems with overarching business objectives. Driving process standardization and regulatory compliance will be at the forefront of your responsibilities. You will lead a dedicated team of quality experts, guiding them in the development and implementation of comprehensive strategies for global regulated processes. Your data-driven decision-making will facilitate the identification of opportunities for quality enhancements. Additionally, you will oversee complex RDQRM projects and manage a comprehensive communication strategy. By ensuring the integrity and effectiveness of our global quality systems, you will reinforce operational excellence and foster a robust culture of compliance. This is an exceptional opportunity to make a significant impact on our organization’s quality landscape.
Who you are:
- You hold an advanced degree (PhD or MSc) in Life Sciences (e.g., Biology, Chemistry, Pharmacy) or possess equivalent professional experience.
- You have over 10 years of experience as a strategic leader in the international Pharmaceutical/Biopharmaceutical sector, focusing on quality management systems and processes.
- You possess in-depth knowledge of GxP areas, particularly GCP, GVP, and GLP, along with a comprehensive understanding of global regulatory requirements like ICH.
- You have demonstrated success in managing complex projects and leading change management initiatives in a global, multicultural environment.
- You are fluent in English and possess strong communication skills, both written and verbal.
- You have proven people leadership skills, with the ability to engage and influence stakeholders at all organizational levels.
- You are experienced in regulatory inspections and audits, and you understand the nuances of pharmaceutical drug development.
- You are equipped with continuous improvement knowledge and familiarity with tools such as Lean, Six Sigma, and Business Process Management.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
Darmstadt
Unlock Your Research Potential: Join the Graduate School LSE!
Embark on an exciting journey at the interface between engineering and life sciences with TU Darmstadt's Graduate School LSE. We are thrilled to announce a unique opportunity for international PhD students under the prestigious Graduate School Scholarship Programme (GSSP) of the German Academic Exchange Service (DAAD). Prof. Dr. Ulrike Nuber - Stem cell and developmental biology:
Three-dimensional (3D) human tissue models generated in the laboratory represent versatile in vitro models for human disease studies, drug development and toxicology assessment. They have the potential to reduce animal testing and hold great promise for regenerative medicine. However, their routine application is hindered by several limitations of the current models. One critical limitation is the lack of control over the precise spatial arrangement of cell types. Another limitation of human tissue models with diameters of more than several hundred µm is the lack of a vascular system that transports oxygen, nutrients, and metabolic waste products to and from cells.
In natural human tissues, morphogen gradients steer the spatial development and maintenance of cell types. We have developed diffusion-based devices beyond the scale of microfluidic ones to regionalize human multicellular assemblies through concentration gradients of small bioactive molecules. Moreover, we harness the intrinsic morphogenetic capacity of vascular cells to generate a microvasculature in multicellular 3D human cell models. This process is supported by the integration of biomaterials into 3D cell cultures. To monitor cellular stages and positions in human tissue models, we have generated hiPSC fluorescent reporter lines by the CRISPR-Cas9 system. Qualification profilePlease carefully review the application requirements and admission process BEFORE submitting your application here: https://www.tu-darmstadt.de/graduate-school-lse/phd_program/funding/daad_gssp/daad_gssp.en.jsp
Applications are exclusively accepted via the online application form
Application deadline: February 28, 2025
Interdisciplinary Research: Explore cutting-edge projects at the intersection of engineering and life sciences
Global Network: Join a vibrant community of scientists and experts from diverse backgrounds.
Excellence in Supervision: Conduct your doctoral studies under the supervision of renowned scientists and benefit from the accompanying PhD programme of the Graduate School LSE
Join us in pushing the boundaries of knowledge and fostering groundbreaking discoveries. Your journey to academic excellence starts here!