Product Owner - Quality Assurance (m/f/d)

Engagiert in der Forschung. Im Einsatz für Patient*innen.

Mit über 120 Jahren Erfahrung und mehr als 17.000 Mitarbeiter*innen in über 20 Ländern widmet sich Daiichi Sankyo der Entdeckung, Entwicklung und Bereitstellung neuer Behandlungsstandards, die die Lebensqualität weltweit verbessern.


In Europa konzentrieren wir uns auf zwei Bereiche: Unser Specialty Business hat es sich zum Ziel gesetzt, Menschen vor Herz-Kreislauf-Erkrankungen, der führenden Todesursache in Europa, zu schützen. Außerdem möchten wir betroffenen Patient*innen helfen, jeden kostbaren Moment des Lebens zu genießen. In der Onkologie streben wir danach, ein weltweit führender Pharma-Innovator mit Wettbewerbsvorteilen zu sein und neue Therapien für Menschen mit Krebs zu entwickeln.


Unser europäischer Hauptsitz befindet sich in München, Deutschland, und wir haben Niederlassungen in 13 europäischen Ländern und Kanada.


Ab sofort suchen wir für unseren Entwicklungs- und Produktionsstandort in Pfaffenhofen/Ilm einen agilen und engagierten


Experte (m/w/d) Studienkoordinierung
(zunächst befristet auf 2 Jahre)


Die Position:

In dieser Position wirken sie aktiv an der Gestaltung von optimierten Arbeitsabläufen und der Einbindung von neuen Projekten im Bereich Studienkoordinierung Klinikmusterverpackung mit. Sie sind an der Ausarbeitung der tätigkeitsbezogenen Prozesse beteiligt sowie an der Gestaltung der Struktur der entsprechenden Chargendokumentation und Erarbeiten eine prozess- und tätigkeitsbezogene Landschaft an Standard-Arbeitsanweisungen (SOPs).

Mitwirkung bei der Organisation einer reibungslosen Auftragsbearbeitung hinsichtlich: Kommunikationsstrategie, Zusammenarbeit, Dokumentation, operative Abarbeitung, Lagerhaltung, Freigabe und Mitwirkung bei der Produktionsplanung
Mitwirkung bei der Erstellung einer qualitativ hochwertigen Chargendokumentation hinsichtlich GMP-Compliance, Effektivität, Anwenderfreundlichkeit und Mitarbeiterschutz
Beteiligung am globalen Clinical Label Management
Zusammenarbeit mit globalen Stakeholdern und Funktionen
Verfolgung einer kontinuierlichen Optimierungsstrategie innerhalb des Aufgabenbereiches
Koordinierung, Erstellung und Schulung von Arbeitsanweisungen
Miterstellung der Verpackungsdokumentation und -struktur für klinische Prüfpräparate
Unterstützung des Studienkoordinierungs-Teams hinsichtlich der Zusammenstellung der Studiendokumentation, Koordination der QP Freigabe, Erstellung von Etikettenlayouts, auftragsbezogene Planung und Beschaffung von benötigten Materialien und Komponenten
Erstellung von tätigkeitsbezogenen Abweichungen und Änderungsverfahren

Hochschulabschluss in Pharmazie
Sehr gute Deutsch- und Englischkenntnisse
Grundlegende GMP-Kenntnisse
Sehr gute PC-Kenntnisse (MS-Office)
Sehr strukturierte, präzise und selbstständige Arbeitsweise
Zeitliche und geistige Flexibilität sowie die Bereitschaft zur Weiterentwicklung und Vorort-Präsenz
Ausdauer und Resilienz im Umgang mit komplexen Aufgabenstellungen
Fähigkeit, Details zu erarbeiten und dabei das große ganze im Blick zu behalten
Gute Kommunikations- und Kollaborationsfähigkeiten
Erfüllung der Kriterien für die Zuverlässigkeitsüberprüfung der Luftfrachtsicherheitsbehörde
Spaß daran, ein stetig wachsendes Team mit zu gestalten und gemeinsam zu experimentieren, zu lernen, zu wachsen und zu lachen

Attraktive Benefits
Work-Life-Benefits
Persönliches Wachstum und Entwicklung
Gesundheit und Wohlbefinden

Engagiert in der Forschung. Im Einsatz für Patient*innen.

Mit über 120 Jahren Erfahrung und mehr als 17.000 Mitarbeiter*innen in über 20 Ländern widmet sich Daiichi Sankyo der Entdeckung, Entwicklung und Bereitstellung neuer Behandlungsstandards, die die Lebensqualität weltweit verbessern.

In Europa konzentrieren wir uns auf zwei Bereiche: Unser Specialty Business hat es sich zum Ziel gesetzt, Menschen vor Herz-Kreislauf-Erkrankungen, der führenden Todesursache in Europa, zu schützen. Außerdem möchten wir betroffenen Patient*innen helfen, jeden kostbaren Moment des Lebens zu genießen. In der Onkologie streben wir danach, ein weltweit führender Pharma-Innovator mit Wettbewerbsvorteilen zu sein und neue Therapien für Menschen mit Krebs zu entwickeln.

Unser europäischer Hauptsitz befindet sich in München, Deutschland, und wir haben Niederlassungen in 13 europäischen Ländern und Kanada. Zum nächstmöglichen Zeitpunkt sucht Daiichi Sankyo Europe in Pfaffenhofen/Ilm eine/n engagierte/n
QM-Representative (m/w/d) - Engineering und Pharma Production / Qualification Group
Planung, Überwachung und Mitwirkung bei Qualifizierungsmaßnahmen und -projekten aus QM-Sicht am Standort in Zusammenarbeit mit den betroffenen Fachbereichen
Review und Genehmigung von Qualifizierungsdokumenten wie Anweisungen, Mas-terplänen, Prüfplänen, Prüfprotokollen, Prüfberichten, sowie Überwachung und Mitwirkung bei deren Umsetzung
Überwachung der Aufrechterhaltung des qualifizierten Zustandes
Verantwortlicher QM-Part im Abweichungs-System: Koordination der Bearbeitung von Quality Events bei der Herstellung und Prüfung von Arzneimitteln, sowie im technischen Bereich
Mitwirkung bei Computervalidierungsprojekten in der Abteilung Quality Management, Erstellung von Life Cycle- und Testdokumenten
Administrative Betreuung der QM-Datenbanken SOPDB, TMDB und CCDB sowie Planung und Durchführung von Schulungen für alle damit arbeitenden Abteilungen des europäischen Headquarters, des Produktionsstandortes, sowie den europäischen Affiliates
Erstellung regelmäßig erforderlicher QM-Reviews
Unterstützung des Vorgesetzten für QM-relevante Tätigkeiten bei Bedarf

Erfolgreich abgeschlossenes naturwissenschaftliches Studium im Bereich Life Sciences (wie z.B. Pharmazie, Biotechnologie, Lebensmitteltechnologe etc.)
Mindestens 3-jährige Erfahrung im Quality Management in der pharmazeutischen Industrie
Mehrjährige Erfahrungen und Kenntnisse in der Qualifizierung von Equipment und IT-Systemen in der pharmazeutischen Industrie
Erfahrungen im technischen und im Produktionsbereich der pharmazeutischen Industrie wünschenswert
Umfangreiche Kenntnisse der nationalen und internationalen GxP-Regelwerke.
Umfangreiche Kenntnisse in der elektronischen Datenverarbeitung (MS Office, SAP, S4Hana, Trackwise Digital)
Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift
Fähigkeit zur interdisziplinären und internationalen Teamarbeit
Strukturierte und selbstständige Arbeitsweise
Zuverlässiger, verantwortungsbewusster und sorgfältiger Arbeitsstil

Attraktive Benefits
Work-Life-Balance
Persönliches Wachstum und Entwicklung
Gesundheit und Wohlbefinden

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.


In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.


Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.


For Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position:


Manager (m/f/x) QA QMS

Purpose of the function:

In the new established role at Daiichi Sankyo Europe GmbH you act as the primary contact for all Quality Management System related topics.
As Manager QA QMS you support and manage all typical QA topics (like Deviations, Complaints, Change Control, Audits etc.) in our electronical QMS system (e.g., Trackwise Digital). Furthermore, you support the global Daiichi Sankyo QA group as an expert and window person in eQMS topics, processes and projects.

Manage QA topics in the existing local QMS:

You are responsible for maintenance, updates etc. as an administrative function for the local eQMS
Support in the creation and usage of KPIs and reports in the eQMS
You are a window person between the existing QA systems and the eQMS in Trackwise Digital. In this role you support transfers from the existing QA systems to the eQMS


Maintain global eQMS based on existing requirements
As a window person you support projects for transferring and improving of existing local QA systems to a global system
Participate in the further development of the corporate eQMS

In global working teams you act as a SME to improve the eQMS on a local and global basis
Share knowledge and expertise within QA or to other functions at DSE




In this role you will work in close cooperation with other departments and sites like the European Headquarter and the European affiliates as well as with other global regions to implement and to ensure a consistent eQMS.

University/FH/Master degree or similar in Life Sciences (like Pharmacy, Biotechnology, Foodtechnology etc.)
At least 3 years of relevant work experience in quality management in the pharmaceutical industry
Several years of experience and knowledge in electronical Quality Management systems in the pharmaceutical industry
Good knowledge of international GxP regulations
Extensive knowledge of electronic data processing, especially in Quality Management (MS Office, Trackwise Digital, S4/Hana, SAP)
A true teamplayer, high quality consciousness and a solution-oriented mindset
Very good written and verbal communication skills in German and English
Ability to work in interdisciplinary and international teams
Structured and independent way of working
Reliable, responsible and meticulous working style
Project management skills is a plus
Willingness to travel

Excellent Benefits
Work-Life-Balance
Growth and Development
Health and Wellbeing Support

Passion for Innovation. Compassion for Patients.
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

For Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position:
Senior Quality Manager CMO (m/f/x) - Drug Product Manufacturing In your new role you act as the primary contact for all quality related topics at contract manufacturing organizations (CMOs). As QM CMO you manage the quality oversight at the CMOs and your responsibilities include implementation and maintaining of DS quality standards (GMP/GDP) and regulatory requirements at external contract manufacturers for our oncology products. Furthermore, you support other DS functions as an expert in quality topics and processes.
Roles and responsibilities:


Manage quality oversight at CMOs

You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
Define together with the CMO effective CAPAs and track the timely implementation
As DS QA you independently review, evaluate and approve documents like APQRs, PPQ reports or CPVs
The QM CMO is the person responsible for preparing and negotiating QAAs with CMOs and ensures the CMOs work in accordance with DS QAAs
You are involved in establishment of new manufacturing processes and site transfer activities and act as quality subject matter expert supporting PPQ and validation activities
You support CMOs during Authority Inspections and perform audits on behalf of DS at different suppliers as needed
In this role you identify quality risks at our CMOs and escalate issues in case it becomes necessary





Act as global information distributor

In your new role you support global teams and SMEs to identify and define quality needs for CMOs
You share quality related information from the CMOs to our global stakeholders within the global QA environment as well as in department overarching meetings





Participate in the further development of the corporate QM-System

In global working teams you act as SME to improve the DS quality system and global SOP landscape
Share knowledge and expertise within QA or to other functions to improvement CMO management at DS



In this role you will work globally in close cooperation with other departments like Supply Chain, CMC, regulatory functions and others to ensure consistent supply to markets with products which meet our high quality standards at any time.
University/FH/Master degree in natural or pharmaceutical sciences - preferred in Pharmacy, Biotechnology, Microbiology or a comparable program
At least five years of relevant work experience in the pharmaceutical industry including:
at least two years in Quality Assurance and/or Quality Management - preferable in Shop Floor QA activities or as QA Oversight for Manufacturing Activities for Sterile Manufacturing
at least two years in a GxP environment in a Fill&Finish manufacturing department for sterile solutions and/or lyophilisates
Excellent knowledge of international GMP/GDP regulations
Expertise in parenteral biological manufacturing particularly in the manufacture of sterile medicinal products or of biological active substances is desired
Have assertiveness, strong communication skill paired with diplomatic attitude during negotiations
A true team p...

Passion for Innovation. Compassion for Patients.
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

For Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position:
Senior Quality Manager CMO (m/f/x) - Drug Product Manufacturing In your new role you act as the primary contact for all quality related topics at contract manufacturing organizations (CMOs). As QM CMO you manage the quality oversight at the CMOs and your responsibilities include implementation and maintaining of DS quality standards (GMP/GDP) and regulatory requirements at external contract manufacturers for our oncology products. Furthermore, you support other DS functions as an expert in quality topics and processes.
Roles and responsibilities:


Manage quality oversight at CMOs

You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
Define together with the CMO effective CAPAs and track the timely implementation
As DS QA you independently review, evaluate and approve documents like APQRs, PPQ reports or CPVs
The QM CMO is the person responsible for preparing and negotiating QAAs with CMOs and ensures the CMOs work in accordance with DS QAAs
You are involved in establishment of new manufacturing processes and site transfer activities and act as quality subject matter expert supporting PPQ and validation activities
You support CMOs during Authority Inspections and perform audits on behalf of DS at different suppliers as needed
In this role you identify quality risks at our CMOs and escalate issues in case it becomes necessary





Act as global information distributor

In your new role you support global teams and SMEs to identify and define quality needs for CMOs
You share quality related information from the CMOs to our global stakeholders within the global QA environment as well as in department overarching meetings





Participate in the further development of the corporate QM-System

In global working teams you act as SME to improve the DS quality system and global SOP landscape
Share knowledge and expertise within QA or to other functions to improvement CMO management at DS



In this role you will work globally in close cooperation with other departments like Supply Chain, CMC, regulatory functions and others to ensure consistent supply to markets with products which meet our high quality standards at any time.
University/FH/Master degree in natural or pharmaceutical sciences - preferred in Pharmacy, Biotechnology, Microbiology or a comparable program
At least five years of relevant work experience in the pharmaceutical industry including:
at least two years in Quality Assurance and/or Quality Management - preferable in Shop Floor QA activities or as QA Oversight for Manufacturing Activities for Sterile Manufacturing
at least two years in a GxP environment in a Fill&Finish manufacturing department for sterile solutions and/or lyophilisates
Excellent knowledge of international GMP/GDP regulations
Expertise in parenteral biological manufacturing particularly in the manufacture of sterile medicinal products or of biological active substances is desired
Have assertiveness, strong communication skill paired with diplomatic attitude during negotiations
A true team p...

Engagiert in der Forschung. Im Einsatz für Patient*innen.

Mit über 120 Jahren Erfahrung und mehr als 17.000 Mitarbeiter*innen in über 20 Ländern widmet sich Daiichi Sankyo der Entdeckung, Entwicklung und Bereitstellung neuer Behandlungsstandards, die die Lebensqualität weltweit verbessern.


In Europa konzentrieren wir uns auf zwei Bereiche: Unser Specialty Business hat es sich zum Ziel gesetzt, Menschen vor Herz-Kreislauf-Erkrankungen, der führenden Todesursache in Europa, zu schützen. Außerdem möchten wir betroffenen Patient*innen helfen, jeden kostbaren Moment des Lebens zu genießen. In der Onkologie streben wir danach, ein weltweit führender Pharma-Innovator mit Wettbewerbsvorteilen zu sein und neue Therapien für Menschen mit Krebs zu entwickeln.


Unser europäischer Hauptsitz befindet sich in München, Deutschland, und wir haben Niederlassungen in 13 europäischen Ländern und Kanada.


Zum nächstmöglichen Zeitpunkt sucht Daiichi Sankyo Europe in Pfaffenhofen/Ilm eine/n engagierte/n


QM-Representative (m/w/d) - Engineering und Pharma Production / Qualification Group
Planung, Überwachung und Mitwirkung bei Qualifizierungsmaßnahmen und -projekten aus QM-Sicht am Standort in Zusammenarbeit mit den betroffenen Fachbereichen
Review und Genehmigung von Qualifizierungsdokumenten wie Anweisungen, Masterplänen, Prüfplänen, Prüfprotokollen, Prüfberichten, sowie Überwachung und Mitwirkung bei deren Umsetzung
Überwachung der Aufrechterhaltung des qualifizierten Zustandes
Verantwortlicher QM-Part im Abweichungs-System: Koordination der Bearbeitung von Quality Events bei der Herstellung und Prüfung von Arzneimitteln, sowie im technischen Bereich
Mitwirkung bei Computervalidierungsprojekten in der Abteilung Quality Management, Erstellung von Life Cycle- und Testdokumenten
Administrative Betreuung der QM-Datenbanken SOPDB, TMDB und CCDB sowie Planung und Durchführung von Schulungen für alle damit arbeitenden Abteilungen des europäischen Headquarters, des Produktionsstandortes, sowie den europäischen Affiliates
Erstellung regelmäßig erforderlicher QM-Reviews
Unterstützung des Vorgesetzten für QM-relevante Tätigkeiten bei Bedarf

Erfolgreich abgeschlossenes naturwissenschaftliches Studium im Bereich Life Sciences (wie z.B. Pharmazie, Biotechnologie, Lebensmitteltechnologe etc.)
Mindestens 3-jährige Erfahrung im Quality Management in der pharmazeutischen Industrie
Mehrjährige Erfahrungen und Kenntnisse in der Qualifizierung von Equipment und IT-Systemen in der pharmazeutischen Industrie
Erfahrungen im technischen und im Produktionsbereich der pharmazeutischen Industrie wünschenswert
Umfangreiche Kenntnisse der nationalen und internationalen GxP-Regelwerke.
Umfangreiche Kenntnisse in der elektronischen Datenverarbeitung (MS Office, SAP, S4Hana, Trackwise Digital)
Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift
Fähigkeit zur interdisziplinären und internationalen Teamarbeit
Strukturierte und selbstständige Arbeitsweise
Zuverlässiger, verantwortungsbewusster und sorgfältiger Arbeitsstil

Excellent Benefits
Work-Life Balance
Growth and Developement
Health and Wellbeing Support

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.


In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.


Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.


For Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position:


Product Owner Quality (m/f/x) - Antibody Drug Conjugates

The Position:

As Product Owner Quality (POQ) you are responsible for ensuring quality oversight for one product at a global level. You act as primary quality contact for the assigned product for both internal and external stakeholders in an international and very dynamic work environment from development until end of commercial life cycle. To do this, you communicate with different functions on management and senior levels in day-to-day business and maintain a strategic overview of quality-related topics and objectives at the same time.
Manage global quality oversight for the assigned product



You are responsible as global quality lead for the assigned product
You work together with different functions from global QA, CMC, Regulatory Affairs and Supply Chain in a matrix organization to define the strategical approach to solve challenges in the day-to-day business
You review and evaluate documents like APQRs, PPQ reports or CTDs
You trend the development of the assigned product from a quality-related perspective and keep the senior management and the team informed about respective developments
You identify quality risks related to the assigned product and in case necessary you escalate issues to senior level management
You keep close contact to the teams managing the manufacturers as well as the MAH related functions
You support the organization during submissions in GMP-related matters and if required during Authority Inspections related to the assigned product


Act as global information distributor



You monitor quality-related information from different markets and clinical studies to ensure a consistent global understanding of the assigned product
You support global teams and SMEs to identify quality-related risks at an early stage and support on every level to find suitable mitigation measures
You collect and share quality related information in all directions to our global stakeholders within the global QA environment as well as in department overarching teams


Participate in the further development of the corporate QM-System



You act as a SME to help improving the global Daiichi-Sankyo QMS and global SOP landscape
Share knowledge and expertise within the DS network to improve QA and CMO management at DS


In this role you will work globally in close cooperation with other departments like Supply Chain, CMC, Regulatory Affairs and others to ensure consistent supply to markets with products which meet our high-quality standards at any time. This requires an extensive understanding of the pharmaceutical industry and multi-cultural work environments.

University/FH/Master degree in natural or pharmaceutical sciences - preferred in Pharmacy, Biotechnology, Microbiology or a comparable program
At least 8+ years of relevant work experience in the pharmaceutical industry including:

at least 4+ years in Quality Assurance and/or Quality Management - preferable in different functions as Shop Floor QA activities, QA Oversight for Manufacturing Activities and/or global QA roles
at least 2+ year ex...

Passion for Innovation. Compassion for Patients.

With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.


In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.


Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.


For Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position:


Team Lead (m/f/x) CMO Management QA

The position:

As Team Lead CMO Management QA you are responsible for leading a team of highly educated and experienced people, which act as primary contact for quality related topics to our Contract Manufacturing Organizations (CMOs). Furthermore, you act as primary contact for assigned overarching, management level related topics for both internal and external stakeholders in an international and very dynamic work environment from development until end of commercial life cycle. Your tasks include day-to-day business as well as strategic related topics and objectives and require communication with different functions and management levels.
Manage a team for quality oversight for CMOs located in Europe



You are responsible as leader for a team of 4-5 people
You work together with different functions from global QA, CMC, Regulatory Affairs and Supply Chain in a matrix organization to support your team to solve challenges in the day-to-day business related to CMO management
You set strategies for optimal day-to-day business operations for your team and make sure the expectations from internal and external stakeholders are fulfilled
You understand the needs of your team and you are able to develop people on a personal and professional level
You are able to interact with management level at CMOs and in case necessary you take over quality-related, overarching topics connected to CMOs
You are able to review and evaluate documents like APQRs, PPQ reports or CTDs if required
You support the organization during Authority Inspections in your area of responsibility and perform audits on behalf of DS at different suppliers as needed


Act as global information distributor



You monitor quality-related information from different markets to ensure early recognition of trends related to your area of responsibility
You provide such information to global teams and SMEs to identify quality-related risks at an early stage and support on every level to find suitable mitigation measures


Participate in the further development of the corporate QM-System



You act as a SME to help improving the global Daiichi-Sankyo QMS and global SOP landscape
Share knowledge and expertise within the DS network to improve QA and CMO management at DS


In this role you will work globally in close cooperation with other departments like Supply Chain, CMC, Regulatory Affairs and others to ensure consistent supply to markets with products which meet our high-quality standards at any time. This requires an extensive understanding of the pharmaceutical industry and multi-cultural work environments.

University/FH/Master degree in natural or pharmaceutical sciences - preferred in Pharmacy, Biotechnology, Biology or a comparable program
At least 8+ years of relevant work experience in the pharmaceutical industry including:

at least 4+ years in Quality Assurance and/or Quality Management - preferable in different functions as Shop Floor QA, QA Oversight for Manufacturing Activities and/or global QA roles
at least 2+ year experience of working in a GMP in manufa...