Senior QA Manager

Vor 6 Tagen

Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

About the Role:

We are seeking a highly qualified Team Lead to join our Quality Assurance team at Daiichi Sankyo Europe. As a Team Lead, you will be responsible for managing a team of quality professionals responsible for overseeing the quality of our Contract Manufacturing Organizations (CMOs) in Europe.

Key Responsibilities:

  • Manage a team of 4-5 quality professionals responsible for quality oversight of CMOs in Europe
  • Work closely with global QA, CMC, Regulatory Affairs, and Supply Chain functions to support the team in solving challenges related to CMO management
  • Develop and implement strategies for optimal day-to-day business operations for the team
  • Ensure that the expectations of internal and external stakeholders are met
  • Develop people on a personal and professional level
  • Interact with management level at CMOs and take over quality-related, overarching topics connected to CMOs
  • Review and evaluate documents such as APQRs, PPQ reports, or CTDs as required
  • Support the organization during Authority Inspections in your area of responsibility and perform audits on behalf of DS at different suppliers as needed

Requirements:

  • University degree in natural or pharmaceutical sciences (preferably 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
  • At least 2+ years of experience working in a GMP manufacturing environment for monoclonal antibodies and/or biological APIs
  • Experience with ADC manufacturing is a strong plus
  • At least 4+ years of experience as a team leader with at least 4-5 direct reports
  • Excellent knowledge of international GMP/GDP regulations
  • Experience in managing relationships with C(D)Mos or external supplier organizations
  • Proven track record of project management and leadership skills in matrix organizations
  • Very good knowledge of CMC regulatory and development
  • Assertiveness, strong communication skills, and a diplomatic attitude during negotiations
  • A true team player, high quality consciousness, and a solution-oriented mindset
  • Ability to manage senior-level relationships within the company and with external partners
  • Very good written and verbal communication skills in English
  • Japan and/or German communication skills is a plus
  • Willingness to travel (up to 10%, domestic and international)

About Daiichi Sankyo Europe:

Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. We have over 120 years of experience and more than 17,000 employees in over 20 countries. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

Why Work with Us:

Working at Daiichi Sankyo Europe is more than just a job – it is your chance to make a difference and change patients' lives for the better. We foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

  • Senior Manager of Global Quality Assurance

    vor 4 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    About Us: At Daiichi Sankyo Europe GmbH, we are dedicated to becoming a leading innovator in the pharmaceutical industry, particularly in the field of Oncology, where we aim to develop groundbreaking therapies for cancer patients. Position Overview: We are looking for a highly skilled professional to take on the role of Senior Manager of Global Quality...

  • Senior Quality Manager CMO

    Vor 4 Tagen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Job SummaryWe are seeking a highly qualified Senior Quality Manager CMO to join our team in Munich, Germany. As a key member of our Quality...

  • Senior Quality Manager CMO

    Vor 6 Tagen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Job SummaryWe are seeking a highly qualified Senior Quality Manager CMO to join our team in Munich, Germany. As a key member of our Quality...

  • Senior Quality Control Manager

    vor 4 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    Passion for Innovation. Compassion for Patients.With a rich history spanning over 120 years and a dedicated workforce of more than 17,000 employees across 20 countries, Daiichi Sankyo is committed to pioneering, developing, and delivering new standards of care that enhance the quality of life globally.Our Focus in Europe:Our Specialty Business aims to...

  • Project Manager

    Vor 2 Tagen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About the RoleWe are seeking a highly skilled Project Manager to join our Quality Management team at Daiichi Sankyo Europe. As a Project Manager, you will be responsible for ensuring the successful implementation of quality management systems and processes in our Fill & Finish and ADC Secondary Packaging departments.Key ResponsibilitiesSupport the QA Project...

  • Project Manager

    Vor 2 Tagen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About the RoleWe are seeking a highly skilled Project Manager to join our Quality Management team at Daiichi Sankyo Europe. As a Project Manager, you will be responsible for ensuring the successful implementation of quality management systems and processes in our Fill & Finish and ADC Secondary Packaging departments.Key ResponsibilitiesSupport the QA Project...

  • Quality Assurance Operations Manager

    vor 4 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    Company Overview: At Daiichi Sankyo Europe GmbH, we are dedicated to becoming a leading innovator in the pharmaceutical industry, focusing on developing advanced therapies for cancer treatment. Position Summary: We are currently looking for a highly skilled professional to join our team as a Senior Quality Manager CMO (m/f/x) - Drug Product Manufacturing. In...

  • Project Manager

    Vor 5 Tagen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company with a rich history of innovation and commitment to improving the lives of patients worldwide. With over 120 years of experience and a global presence in over 20 countries, we are dedicated to discovering, developing, and delivering new treatment standards that enhance the...

  • Global Quality Assurance Lead

    vor 4 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    Company Overview: At Daiichi Sankyo Europe GmbH, we are dedicated to becoming a leading innovator in the pharmaceutical industry, focusing on developing groundbreaking therapies for cancer treatment. Position Summary: We are currently looking for a qualified professional to join our team as a Senior Quality Manager CMO (m/f/x) - Drug Product Manufacturing....

  • Head of Quality Assurance for CMO

    vor 4 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    About the Role: In the field of Oncology, our mission is to emerge as a leading global pharmaceutical innovator, dedicated to developing groundbreaking therapies for cancer patients. Position Overview: We are looking for an exceptional candidate to take on the role of Senior Quality Manager CMO (m/f/x) - Drug Product Manufacturing. In this pivotal position,...

  • Senior Process Manager

    vor 1 Woche

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    About Daiichi Sankyo Europe GmbHDaiichi Sankyo Europe GmbH is a leading pharmaceutical company with over 120 years of experience and a presence in over 20 countries. Our mission is to discover, develop, and deliver innovative treatments that improve the quality of life for patients worldwide.Our Focus AreasWe are dedicated to two key areas: protecting people...

  • Senior Quality Manager CMO

    vor 1 Woche

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Senior Quality Manager CMO (m/f/x) – Drug Product ManufacturingKey Responsibilities:Oversee quality oversight at Contract Manufacturing Organizations (CMOs)Act as a global information distributor for quality-related mattersContribute to the further development of the corporate Quality Management System (QMS)Requirements:University degree in a natural or...

  • Senior Quality Manager CMO

    Vor 4 Tagen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    Senior Quality Manager CMO (m/f/x) – Drug Product ManufacturingKey Responsibilities:Oversee quality oversight at Contract Manufacturing Organizations (CMOs)Act as a global information distributor for quality-related mattersContribute to the further development of the corporate Quality Management System (QMS)Requirements:University degree in a natural or...

  • Senior Quality Manager CMO

    vor 1 Tag

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Job SummaryWe are seeking a highly qualified Senior Quality Manager CMO to join our team in Munich, Germany. As a key member of our global...

  • Senior Quality Manager CMO

    vor 1 Tag

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Job SummaryWe are seeking a highly qualified Senior Quality Manager CMO to join our team in Munich, Germany. As a key member of our global...

  • Senior Process Manager

    Vor 3 Tagen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    About Daiichi Sankyo Europe GmbHDaiichi Sankyo Europe GmbH is a leading pharmaceutical company with a rich history of innovation and dedication to improving patient outcomes. With a strong presence in Europe, we are committed to discovering, developing, and delivering new standards of care that enrich the quality of life for people around the world.Our...

  • Senior Process Manager

    Vor 3 Tagen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    About Daiichi Sankyo Europe GmbHDaiichi Sankyo Europe GmbH is a leading pharmaceutical company with a rich history of innovation and dedication to improving patient outcomes. With a strong presence in Europe, we are committed to discovering, developing, and delivering new standards of care that enrich the quality of life for people around the world.Our...

  • Senior Quality Manager CMO

    Vor 6 Tagen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and...

  • Senior Quality Manager CMO

    Vor 5 Tagen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and...

  • Senior Quality Manager CMO

    vor 2 Wochen

    Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit

    About Daiichi Sankyo EuropeDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer and...