Senior Quality Manager CMO (m/f/x) - Drug Substance Manufacturing

JR Germany; Pfaffenhofen an der Ilm; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen im Bereich der biopharmazeutischen Entwicklung sucht einen Senior Quality Manager. In dieser Schlüsselposition sind Sie für die Qualitätssicherung bei Vertragsherstellern verantwortlich und stellen sicher, dass die höchsten Standards für GMP/GDP eingehalten werden. Sie arbeiten eng mit verschiedenen Abteilungen zusammen, um die Qualität der Produkte zu gewährleisten und Risiken zu identifizieren. Wenn Sie eine Leidenschaft für Qualität und Compliance haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die ideale Gelegenheit für Sie.

Qualifikationen

• Mindestens fünf Jahre Erfahrung in der pharmazeutischen Industrie.
• Zwei Jahre Erfahrung in Qualitätssicherung oder Management.

Aufgaben

• Verantwortlich für die Qualitätssicherung bei Vertragsherstellern.
• Unterstützung bei der Entwicklung des Unternehmensqualitätssystems.

Kenntnisse

Qualitätsmanagement

GMP/GDP Vorschriften

Verhandlungsgeschick

Projektmanagement

Kommunikationsfähigkeiten

Ausbildung

Master in Natur- oder Pharmawissenschaften

Jobbeschreibung

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Senior Quality Manager CMO (m/f/x) - Drug Substance Manufacturing, Pfaffenhofen an der Ilm

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Location:

Job Category: Other

EU work permit required: Yes

Job Views:

2

Posted:

08.05.2025

Expiry Date:

22.06.2025

Job Description:

Daiichi Sankyo, with over 120 years of experience and approximately 19,000 employees across more than 30 countries, is dedicated to discovering, developing, and delivering innovative care standards that improve quality of life globally.

Our European focus is on protecting against cardiovascular disease and advancing oncology through groundbreaking science, aiming to improve outcomes for patients and their loved ones.

Headquartered in Munich, Germany, with affiliates in 15 European countries and Canada, we are seeking a highly qualified candidate for the role of:

Senior Quality Manager CMO (m/f/x) – Drug Substance Manufacturing

Purpose of the role:

You will serve as the primary contact for quality-related topics at contract manufacturing organizations (CMOs), overseeing quality standards (GMP/GDP) and regulatory compliance for our oncology drug substances. Your responsibilities include supporting other DS functions as a quality expert.

• Manage quality oversight at CMOs:
  • Handle topics like change control, deviations, and complaints related to DS products at CMOs.
  • Define and track effective CAPAs with the CMO.
  • Review, evaluate, and approve documents such as APQRs, PPQ reports, or CPVs.
  • Negotiate and ensure compliance with QA agreements with CMOs.
  • Support establishment of new manufacturing processes and site transfers, acting as quality SME during PPQ and validation activities.
  • Assist during authority inspections and conduct audits at suppliers.
  • Identify and escalate quality risks at CMOs.
• Act as a global information distributor:
  • Support global teams and SMEs in defining quality needs for CMOs.
  • Share quality information with global stakeholders within the QA environment and across departments.
• Participate in the development of the corporate QM system:
  • Act as SME in global teams to improve the DS quality system and SOP landscape.
  • Share knowledge to enhance CMO management at DS.

This role involves close cooperation with departments like Supply Chain, CMC, and Regulatory Affairs to ensure a consistent supply of high-quality products globally.

Minimum Qualifications:

• University/FH/Master in natural or pharmaceutical sciences, preferably Biotechnology, Bioengineering, or Biochemistry.
• At least five years in the pharmaceutical industry, including:
• Two years in Quality Assurance/Management, preferably in Shop Floor QA or QA oversight of manufacturing.
• Two years in a GxP environment in drug substance manufacturing for chemical or biological products.
• Excellent knowledge of GMP/GDP regulations.
• Experience with ADC drug substances or biological active substances is preferred.
• Assertiveness, strong communication, and diplomatic negotiation skills.
• Team-oriented, high quality consciousness, solution-minded.
• Fluent in English and German, both written and verbal.
• Experience managing CMOs or external suppliers is beneficial.
• Project management skills are a plus.
• Willingness to travel (up to 10%), domestic and international.