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

TN Germany; Pfaffenhofen an der Ilm; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in pharmaceutical innovation is seeking a Senior Quality Manager CMO to oversee quality at contract manufacturing organizations. The role requires expertise in quality assurance and compliance, ensuring high standards in drug product manufacturing.

Qualifikationen

• At least five years of relevant experience in the pharmaceutical industry.
• At least two years in Quality Assurance/Management.

Aufgaben

• Manage quality oversight at CMOs, including change control and deviations.
• Act as a global information distributor for quality needs.
• Participate in the development of the corporate QM-System.

Kenntnisse

Quality Assurance

GMP

Biotechnology

Microbiology

Ausbildung

University/FH/Master degree in natural or pharmaceutical sciences

Jobbeschreibung

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

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Job Reference:

68a028b1adf8

Job Views:

1

Posted:

11.05.2025

Expiry Date:

25.06.2025

Job Description:

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 a 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

Purpose of the role:

Roles and responsibilities:

1. Manage quality oversight at CMOs, including topics like change control, deviations, and complaints related to DS products. Define effective CAPAs with the CMO and track their implementation. Review and approve documents such as APQRs, PPQ reports, or CPVs. Prepare and negotiate QAAs with CMOs, ensuring compliance. Support establishment of new manufacturing processes and site transfer activities. Support CMOs during Authority Inspections and perform audits. Identify and escalate quality risks.
2. Act as a global information distributor, supporting global teams and SMEs to identify and define quality needs for CMOs. Share quality information with global stakeholders.
3. Participate in the development of the corporate QM-System, acting as SME to improve the DS quality system and SOP landscape. Share knowledge within QA and other functions to improve CMO management.

Work closely with departments like Supply Chain, CMC, and regulatory functions to ensure consistent supply of high-quality products globally.

Personal skills and professional experience:

• University/FH/Master degree in natural or pharmaceutical sciences, preferably in Pharmacy, Biotechnology, Microbiology, or similar.
• At least five years of relevant experience in the pharmaceutical industry, including:
• At least two years in Quality Assurance/Management, preferably in Shop Floor QA or oversight of manufacturing activities for sterile products.
• At least two years in a GxP environment in a Fill & Finish department for sterile solutions or lyophilisates.
• Excellent knowledge of GMP/GDP regulations.
• Expertise in parenteral biological manufacturing, especially sterile medicinal products or biological active substances, is desired.