(Senior) Manager Quality Management Biopharma (m/f/d)

As (Senior) Manager Quality Management Biopharma (m/f/d), it is your responsibility to provide Quality Assurance and Quality Management oversight, ensuring that biopharmaceuticals are developed, manufactured, tested, stored, and distributed in compliance with current Good Manufacturing Practices (GMP) and other applicable regulations. You will oversee the entire supply chain, including third-party manufacturers (C(D)MOs) and suppliers, ensuring compliance and quality throughout the product lifecycle.

Your tasks:

• Act as the Quality Contact/Product Quality Lead for externally developed and/or manufactured biopharmaceuticals

• Manage GMP/GDP/MDR quality oversight of Third-Party Manufacturers (TPMs), testing labs, medical device suppliers, packagers, and carriers by:

• Planning and conducting vendor audits, including monitoring CAPA progress until completion
• Negotiating, establishing, and maintaining quality agreements
• Defining Key Quality Indicators (KQIs) and Key Compliance Indicators (KCIs), collecting data for periodic management reviews to identify and mitigate risks
• Supporting inspection readiness programs for production units
• Assisting with technology transfer and analytical transfer activities
•  on-site presence during critical activities (e.g., PPQ campaigns, tech transfers, health authority inspections), if required

• Oversee foreign trade business of TPM products in collaboration with the Responsible Person/Qualified Person and other Fresenius Kabi units, such as PU TPM EU, TPM US, and TPM FKSBS

• Manage internal and external change controls, deviations, events, CAPAs, and complaints related to drug substances, drug products, combination products, and finished products, liaising with relevant business unit functions, production units, and TPMs

• Lead continuous improvement and harmonization projects focused on quality-related processes for trading commercial medicinal products

Your profile:

• Degree in pharmacy, biotechnology or related field (BA/BS, MA/MS, or PhD)

• At least five years of experience in Quality Operations within biotech, life sciences, or pharmaceutical industry

• Strong knowledge of Quality Standards (ISO 9001, ISO 13485, ICH Q8, Q9, Q10) and cGMP requirements for pharmaceuticals and combination products (Eudralex, 21 CFR 210, 211, 600)

• Experience with regulatory agencies (e.g., FDA, EMA) and third-party quality management

• Qualification as a Qualified Person (§15 AMG) is a plus

• Fluent in English and German (French is a plus)

• Strong leadership, communication, and teamwork skills

• Proven problem-solving and decision-making abilities

• Goal-oriented, proactive, and adaptable

• Willingness to travel (approx. 20%)