Product Owner Quality Specialist

vor 1 Woche

Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit
Job Title: Product Owner Quality

About the Role:

We are seeking a highly qualified Product Owner Quality to join our team at Daiichi Sankyo Europe GmbH. As a global quality lead, you will be responsible for managing quality oversight for assigned products, working closely with global QA, CMC, Regulatory Affairs, and Supply Chain teams to define strategic approaches to solve challenges in the day-to-day business.

Key Responsibilities:

  • Manage global quality oversight for assigned products, including reviewing and evaluating documents like APQRs, PPQ reports, and CTDs.
  • Act as a global information distributor, monitoring quality-related information from different markets and clinical studies to ensure a consistent global understanding of assigned products.
  • Participate in the further development of the corporate QM-System, acting as a SME to help improve the global Daiichi-Sankyo QMS and global SOP landscape.

Requirements:

  • University/FH/Master degree in natural or pharmaceutical sciences, preferably 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, preferably in different functions such as Shop Floor QA activities, QA Oversight for Manufacturing Activities, and/or global QA roles.
  • Excellent knowledge of international GMP/GDP regulations, proven track record of Project management and Leadership skills, and very good knowledge of CMC regulatory and development.
  • Expertise in Supply Chain and global demand planning is desired, as well as assertiveness, strong communication skills, and a diplomatic attitude during negotiations.
  • A true team player, high quality consciousness, and a solution-oriented mindset are essential.

Why Work with Us?

At Daiichi Sankyo, we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. We offer a dynamic and challenging work environment, where 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.

  • Product Owner Quality Specialist

    Vor 7 Tagen

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

    Join Daiichi Sankyo Europe as a Product Owner Quality SpecialistWe are seeking a highly qualified candidate to fill the position of Product Owner Quality Specialist in our European headquarters in Munich, Germany.Key Responsibilities:Manage global quality oversight for assigned productsAct as global information distributorParticipate in the further...

  • Product Owner Quality Specialist

    vor 4 Wochen

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

    Job Title: Product Owner QualityAbout the Role:We are seeking a highly qualified Product Owner Quality to join our team at Daiichi Sankyo Europe GmbH. As a global quality lead, you will be responsible for managing quality oversight for assigned products, working closely with global QA, CMC, Regulatory Affairs, and Supply Chain teams to define strategic...

  • Product Owner Quality Specialist

    vor 4 Wochen

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

    Job Title: Product Owner QualityAbout the Role:We are seeking a highly qualified Product Owner Quality to join our team at Daiichi Sankyo Europe GmbH. As a global quality lead, you will be responsible for managing quality oversight for assigned products, working closely with global QA, CMC, Regulatory Affairs, and Supply Chain teams to define strategic...

  • Product Owner Quality Specialist

    vor 3 Wochen

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

    Job Title: Product Owner QualityAbout the Role:We are seeking a highly qualified Product Owner Quality to join our team at Daiichi Sankyo Europe GmbH. As a global quality lead, you will be responsible for managing quality oversight for assigned products, working closely with global QA, CMC, Regulatory Affairs, and Supply Chain teams to define strategic...

  • Product Owner Quality Specialist

    vor 3 Wochen

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

    Job Title: Product Owner QualityAbout the Role:We are seeking a highly qualified Product Owner Quality to join our team at Daiichi Sankyo Europe GmbH. As a global quality lead, you will be responsible for managing quality oversight for assigned products, working closely with global QA, CMC, Regulatory Affairs, and Supply Chain teams to define strategic...

  • Product Owner Quality Lead

    Vor 3 Tagen

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

    Transforming Patient Lives through Quality ExcellenceDaiichi Sankyo Europe is seeking a highly skilled Product Owner Quality Lead to join our team. As a key member of our global quality oversight team, you will be responsible for managing quality-related activities for our assigned product, ensuring compliance with international GMP/GDP regulations.Key...

  • Senior Quality Manager CMO

    vor 1 Woche

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

    Job Title: Senior Quality Manager CMO - Drug Product ManufacturingAt Daiichi Sankyo Europe, we are seeking a highly qualified Senior Quality Manager CMO to join our team. This role will be responsible for managing quality oversight at Contract Manufacturing Organizations (CMOs) and ensuring that our products meet the highest quality standards.Key...

  • Senior Quality Manager CMO

    vor 4 Stunden

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

    Passion for Innovation. Compassion for Patients.Daiichi Sankyo Europe is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.We are seeking a highly qualified candidate to fill...

  • CMO Quality Oversight Specialist

    vor 2 Monaten

    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...

  • CMO Quality Oversight Specialist

    vor 2 Monaten

    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 3 Tagen

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

    Passion for Innovation. Compassion for Patients.Daiichi Sankyo Europe is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. As a leading pharmaceutical company, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.Our...

  • Product Owner

    vor 3 Wochen

    Landau an der Isar, Bayern, Deutschland AMDT Vollzeit

    Role OverviewWe are seeking a seasoned Product Owner to spearhead the evolution of our flagship product, octoplant. As a visionary leader, you will refine and drive the product vision with customers and our product and development teams, taking end-to-end ownership of the productization process. Your strategic acumen and passion for Automated Production will...

  • Product Owner

    vor 3 Wochen

    Landau an der Isar, Bayern, Deutschland AMDT Vollzeit

    Role OverviewWe are seeking a seasoned Product Owner to spearhead the evolution of our flagship product, octoplant. As a visionary leader, you will refine and drive the product vision with customers and our product and development teams, taking end-to-end ownership of the productization process. Your strategic acumen and passion for Automated Production will...

  • Quality Assurance Specialist

    vor 2 Wochen

    Garching an der Alz, Bayern, Deutschland OncoBeta - epidermal radioisotope therapy Vollzeit

    Join Our Team as a Quality and Regulatory Compliance ManagerWe are seeking a highly skilled Quality and Regulatory Compliance Manager to join our dynamic team at OncoBeta, a leading medical device company. As a key member of our quality management and regulatory affairs department, you will play a critical role in ensuring the compliance of our products with...

  • Quality Assurance Specialist

    vor 2 Wochen

    Garching an der Alz, Bayern, Deutschland OncoBeta - epidermal radioisotope therapy Vollzeit

    Join Our Team as a Quality and Regulatory Compliance ManagerWe are seeking a highly skilled Quality and Regulatory Compliance Manager to join our dynamic team at OncoBeta, a leading medical device company. As a key member of our quality management and regulatory affairs department, you will play a critical role in ensuring the compliance of our products with...

  • Product Owner

    vor 1 Monat

    Landau an der Isar, Bayern, Deutschland AMDT Vollzeit

    Role OverviewWe are seeking a seasoned Product Owner to lead the evolution of our key product, octoplant. As a visionary and strategic thinker, you will refine and drive the product vision with customers and our product and development teams, taking end-to-end ownership of the productization process. Your role will be to act as the voice of the customer,...

  • Product Owner

    vor 1 Monat

    Landau an der Isar, Bayern, Deutschland AMDT Vollzeit

    Role OverviewWe are seeking a seasoned Product Owner to lead the evolution of our key product, octoplant. As a visionary and strategic thinker, you will refine and drive the product vision with customers and our product and development teams, taking end-to-end ownership of the productization process. Your role will be to act as the voice of the customer,...

  • Senior Quality Manager CMO

    Vor 2 Tagen

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

    Passion for Innovation. Compassion for Patients.Daiichi Sankyo Europe is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. As a Senior Quality Manager CMO, you will play a crucial role in ensuring the quality of our products manufactured by Contract Manufacturing Organizations...

  • Product Owner

    Vor 5 Tagen

    Landau an der Isar, Bayern, Deutschland AMDT Vollzeit

    Role OverviewWe are seeking a highly skilled Product Owner to lead the evolution of our key product. As a visionary, you will refine and drive the product vision with customers and our product and development teams, taking end-to-end ownership of the productization process. Your strategic acumen and passion for Automated Production will catalyze our mission...

  • Quality Oversight Specialist

    vor 2 Monaten

    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 experienced Team Lead to join our Quality Assurance team in Munich, Germany. As a Team Lead, you will be...