Job Specifications
Quality Control Manager
Location: Nouvelle-Aquitaine, France (Hybrid)
Department: Quality Control
The role
An established pharmaceutical manufacturing site specialising in aseptic fill/finish of sterile injectable and biologic products is seeking a Quality Control Manager to lead QC activities in a GMP-regulated environment. Reporting to the Head of Quality, the Quality Control Manager is responsible for ensuring analytical excellence, sterility assurance and regulatory compliance in support of aseptic manufacturing operations. The role includes leadership of a QC team and a strong focus on data-driven performance, change management and continuous improvement.
Key responsibilities
QC Leadership & Aseptic Manufacturing Support
Lead, manage and develop a Quality Control team supporting aseptic fill/finish operations.
Ensure timely and compliant execution of QC activities in line with GMP and internal quality standards.
Act as a key QC interface for aseptic manufacturing activities, including preparation, execution and post-campaign support.
Analytical & Microbiological Oversight
Provide technical oversight of chemical and microbiological QC testing, including environmental monitoring, sterility testing, endotoxin and bioburden.
Ensure robustness, compliance and lifecycle management of analytical methods used for sterile injectable products.
Review, trend and interpret QC and environmental monitoring data to support sterility assurance.
Data Integrity & Performance Monitoring
Ensure compliance with data integrity principles (ALCOA+) across laboratory and QC systems.
Define and monitor QC KPIs and performance metrics to support operational and quality decision-making.
Promote a strong quality culture focused on inspection readiness and right-first-time execution.
Change Management & Continuous Improvement
Lead QC-related change controls, including impact assessments related to aseptic operations and laboratory activities.
Drive continuous improvement initiatives in collaboration with Manufacturing, Quality Assurance, Engineering and Operational Excellence teams.
Support standardisation, efficiency and robustness improvements within the QC organisation.
Deviation, Investigation & Audit Support
Oversee QC deviations, OOS/OOT investigations and CAPA activities.
Ensure timely root cause analysis, corrective actions and effectiveness checks.
Support regulatory authority and customer audits, including preparation and follow-up activities.
People Leadership & Development
Recruit, onboard and develop QC team members.
Set objectives, conduct performance reviews and support ongoing capability and talent development.
Foster engagement, accountability and a collaborative working environment.
Candidate profile
Scientific degree in Chemistry, Biochemistry, Microbiology, Biotechnology, Pharmacy or equivalent.
5+ years’ experience in Quality Control within a GMP aseptic manufacturing environment.
Demonstrated experience supporting sterile injectable and/or biologic products.
Strong knowledge of GMP requirements, including EU GMP Annex 1 and contamination control principles.
Experience leading QC teams and managing change in regulated environments.
Analytical, data-driven mindset with strong problem-solving skills.
Experience with deviations, change controls, CAPA and audit readiness.
Professional proficiency in English; French working proficiency preferred.
Familiarity with laboratory IT systems (e.g. LIMS) and standard office software.
About the Company
We are Hlx Life Sciences. A specialised talent consultancy addressing the critical shortage of skilled professionals in the life sciences sector worldwide.
Drawing from our leadership and advisory boards first-hand experience, we understand the unique challenges faced by growing Life Science organisations.
With a variety of services that will revolutionise the talent services market, our offices in Basel and London are positioned to make a meaningful global impact and drive positive change in the life sciences industry.
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