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

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

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 healthcare solutions to improve lives worldwide.

Our European focus lies in two main areas: Protecting people from cardiovascular diseases through our Specialty Business, and advancing innovation in oncology, particularly in solid tumors and blood cancers, based on groundbreaking science from our labs in Japan.

Our European headquarters are located in Munich, Germany, with affiliates in 15 European countries and Canada.

We are seeking a highly qualified Senior Quality Manager CMO (m/f/x) – Drug Product Manufacturing for our European operations.

Purpose of the Role:

You will serve as the primary contact for all quality-related topics at contract manufacturing organizations (CMOs). Your responsibilities include overseeing quality standards (GMP/GDP), ensuring regulatory compliance at external contract manufacturers for oncology products, and supporting other Daiichi Sankyo functions as a quality expert.

Key Responsibilities:

1. Manage quality oversight at CMOs, including:

• Handling quality topics such as change control, deviations, and complaints related to Daiichi Sankyo products.
• Defining and tracking effective CAPAs with the CMO.
• Reviewing, evaluating, and approving documents like APQRs, PPQ reports, or CPVs.
• Preparing and negotiating QAAs with CMOs, ensuring compliance with DS QAAs.
• Supporting establishment of new manufacturing processes and site transfer activities, including PPQ and validation support.
• Supporting CMOs during authority inspections and conducting audits as needed.
• Identifying quality risks and escalating issues accordingly.

• Support global teams and SMEs in identifying and defining quality needs for CMOs.
• Share quality-related information with global stakeholders within the QA environment and department meetings.

• Act as SME in global teams to improve the DS quality system and SOP landscape.
• Share knowledge within QA and other functions to enhance CMO management.

This role involves close collaboration with departments such as Supply Chain, CMC, and regulatory functions to ensure consistent supply of high-quality products to markets worldwide.

Minimum Qualifications:

• University/FH/Master degree in natural or pharmaceutical sciences, preferably in Pharmacy, Biotechnology, Microbiology, or similar.
• At least five years of relevant pharmaceutical industry experience, including:
• Minimum two years in Quality Assurance/Management, preferably in Shop Floor QA or QA oversight for sterile manufacturing.
• Minimum 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 preferred.
• Assertiveness, strong communication skills, and diplomatic negotiation abilities.
• Team-oriented with high quality consciousness and a solution-focused mindset.
• Fluent in English and German, both written and verbal.
• Experience managing CMOs or external suppliers is advantageous.
• Project management skills are a plus.
• Willingness to travel up to 10%, domestically and internationally.