Quality Assurance Compliance Specialist

Quality Assurance Compliance Consultant (m/f/d)

Responsibilities

• Provide consulting support and recommendations for the implementation and optimization of processes at the interface between Regional Quality and Site Quality, with a focus on release management.
• Create and maintain drafts for customer- and country-specific release specifications and certificate requirements.
• Support country release activities in coordination with Quality Assurance, Supply Chain Management, Production, and Packaging.
• Conduct EU MAH assessments for global changes and deviations within the scope of consulting projects.
• Evaluate supplier impacts related to partner‑proposed changes (e.g. expansion into new markets).
• Review Product Technical Specifications (PTS).
• Prepare and update SOP drafts and Quality Agreements (QAAs) for internal approval processes.
• Support the timely and GMP‑compliant handling of deviations, complaints, CAPAs, and change controls through analysis, documentation, and corrective action recommendations.
• Act as a subject matter expert for compliance‑related topics within project environments for internal and external stakeholders.
• Coordinate professionally with the responsible Qualified Person (QP).

Qualifications

• Degree in Life Sciences (e.g. Pharmacy, Chemistry, Biology) or a comparable qualification preferred.
• Several years of professional experience in a GMP‑regulated environment with a strong focus on Quality Assurance and Compliance (e.g. deviation and complaint management, CAPA processes, change control, OOX investigations).
• Several years of experience in Quality Assurance within sterile biopharmaceutical manufacturing environments, preferably involving ADC or mAB production, is considered a strong advantage.
• In‑depth knowledge of regulatory requirements and guidelines (EU‑GMP, ICH guidelines, ideally FDA regulations).
• Experience working with electronic Quality Management Systems (e.g. TrackWise Digital).
• Experience with SAP/S4 HANA.
• Strong quality and compliance mindset.
• High attention to detail and a structured, documentation‑focused way of working.
• Strong analytical and problem‑solving skills.
• Ability to independently prioritize tasks and provide sound professional recommendations.
• Excellent communication skills in professional stakeholder environments.
• Fluent German and English skills, both written and spoken.