Head of Quality Control (m/w/d) - Bioanalytics - #2634062

Our client is a well‑established pharmaceutical organisation operating within a highly regulated GMP environment, supporting global manufacturing and supply activities for complex medicinal products. The organisation places strong emphasis on quality governance, inspection readiness, and regulatory compliance as critical elements of patient safety.
Quality Control operations are embedded within mature quality systems and aligned with European and international regulatory expectations, supporting both commercial manufacturing and advanced development programmes. The environment is scientifically demanding and characterised by close collaboration across Quality, Manufacturing, and Development functions.



About the Role

This is a senior Quality Control leadership position with responsibility for the bioanalytical laboratory.
The role combines scientific accountability, GMP oversight, and people leadership, ensuring that all bioanalytical testing activities are conducted in compliance with regulatory requirements, marketing authorisation documentation, and current scientific standards.
You will be responsible for the design, execution, and continuous improvement of QC bioanalytical processes, while maintaining inspection readiness and representing the function during audits and regulatory inspections. The position works closely with Quality Assurance, Manufacturing, Development, and Qualified Persons.



Key Responsibilities

• Fulfilment of all responsibilities of the Head of Quality Control in accordance with EU‑GMP and AMWHV (§12)
• Overall accountability for GMP‑compliant bioanalytical testing in routine operations and product release
• Scientific review and approval of analytical results supporting manufacturing and release processes
• Evaluation and approval of deviations, OOS/OOT/OOE investigations, CAPAs, change controls, and APR/PQR content
• Authoring, review, and approval of GMP‑relevant documentation (SOPs, analytical instructions, protocols, reports)
• Close collaboration with QA, Production, Development, laboratory teams, and QPs
• Acting as key contact for method transfers, stability studies, development support, and technical reporting
• Planning and management of laboratory resources, capacity, priorities, and project activities
• Assessment and implementation of new analytical technologies to improve robustness and efficiency
• Representation of the bioanalytical QC function during internal and external audits and regulatory inspections
• Leadership, development, and performance management of the laboratory team

Your Profile

• Degree in a natural science discipline (e.g. Biochemistry, Molecular Biology, Pharmacy)
• Several years of experience in bioanalytics within pharmaceutical Quality Control
• Broad technical expertise in bioanalytical methodologies (e.g. bioassays, immunoassays, electrophoretic and molecular techniques)
• Solid and applied knowledge of GMP requirements in a regulated QC environment
• Proven leadership capability within scientifically and regulatory complex settings
• Structured, risk‑based and solution‑oriented working style
• Clear and professional communication with internal and external stakeholders
• Very good English and German kills

Why This Role

• Senior QC leadership role with clear regulatory accountability
• High scientific complexity within a regulated manufacturing environment
• Strong cross‑functional exposure across Quality, Manufacturing, and Development
• Long‑term opportunity within a stable and compliance‑driven organisation
  

SThree_Germany is acting as an Employment Agency in relation to this vacancy.