Senior Quality Manager (m/f/d) - CMO - Monoclonal Antibody

Join an international, research‑driven biopharmaceutical organization that is rapidly expanding its presence in biologics, oncology, and next‑generation antibody technologies. This company combines the stability of a global pharma leader with the dynamic, solution‑oriented mindset of a biotech environment.

Here, experienced Quality professionals are empowered to take ownership, shape external manufacturing standards, and play a vital role in ensuring compliant, reliable supply of high‑impact oncology therapies. If you enjoy working at the interface of QA, biologics manufacturing, and CMO oversight , this is an opportunity to create true value for patients worldwide.

As Senior Quality Manager , you will serve as the primary Quality contact for multiple external manufacturing partners producing monoclonal antibodies. You will drive quality oversight, ensure regulatory compliance, and represent the company as a Quality Subject Matter Expert in cross‑functional and global teams.

This role is ideal for seasoned QA professionals who thrive in complex biologics environments, enjoy collaboration with external partners, and bring the leadership needed to maintain and elevate quality performance across the CMO network.

Your Responsibilities

• Lead QA oversight for CMOs (deviations, CAPAs, change control, complaints).
• Review and approve key GMP documents (APQRs, PPQ reports, batch records, CPV).
• Prepare and negotiate Quality Agreements (QAAs).
• Support tech transfers, validation, and PPQ activities.
• Conduct audits and support regulatory inspections.
• Communicate CMO‑related quality topics to global QA and cross‑functional teams.
• Contribute to continuous improvement and global SOP development.

What You Bring

• Master's degree in Biotechnology, Biochemistry, Pharma or similar.
• 5+ years pharma/biotech experience, incl. 3 years QA .
• 3+ years hands‑on GMP manufacturing.
• 3+ years authoring GMP documents (SOPs, batch records, MI).
• Experience with CMOs; biologics/mAb background is required.
• Bioconjugation (ADC/protein/peptide) experience is a plus.
• Strong knowledge of EU/international GMP/GDP.
• German: Fluent (must‑have) | English: Fluent .
• Willingness to travel ~10%.

Why Join?

• High‑impact role supporting global oncology products.
• International teams, flexible hybrid work model.
• Strong development opportunities in a growing QA environment.
• Inclusive culture where proactive input is valued.