- Company Name
- Hlx Life Sciences
- Job Title
- Quality Control Manager
- Job Description
-
Job title: Quality Control Manager
Role Summary: Lead and manage a QC team in a GMP‑regulated aseptic fill/finish pharmaceutical site, ensuring analytical excellence, sterility assurance, and regulatory compliance while driving continuous improvement and data integrity.
Expactations: Deliver timely, compliant QC execution; maintain robust analytical methods; lead change controls and CAPA; foster a quality‑centric culture; support audit readiness and operational excellence.
Key Responsibilities:
- Head QC operations supporting aseptic manufacturing, ensuring adherence to GMP and internal standards.
- Serve as the primary QC interface for all aseptic fill/finish activities, including preparation, execution and post‑campaign support.
- Oversee chemical, microbiological, environmental monitoring, sterility, endotoxin, and bioburden testing; validate and review analytical methods.
- Analyze and trend QC and environmental data to confirm sterility assurance and drive decision‑making.
- Enforce data integrity (ALCOA+) across labs and QC systems; define and track QC KPIs and performance metrics.
- Lead QC change controls, assess impacts on aseptic processes and laboratory activities.
- Champion continuous improvement initiatives with Manufacturing, QA, Engineering, and OpEx to standardize and enhance QC processes.
- Manage deviations, OOS/OOT investigations, CAPA cycle, root‑cause analyses, and corrective actions.
- Support regulatory and customer audit preparations, documentation, and follow‑up.
- Recruit, onboard, coach, and evaluate QC personnel; set objectives and promote professional development.
Required Skills:
- GMP expertise, EU GMP Annex 1, contamination control principles.
- Strong analytical, problem‑solving, and data‑driven mindset.
- Proven experience in aseptic QC for sterile injectables/biologics.
- Proficiency in change control, CAPA, deviation management, and audit readiness.
- Leadership of QC teams in a regulated environment.
- Familiarity with LIMS and standard office software.
- Professional proficiency in English (French working knowledge optional).
Required Education & Certifications:
- Bachelor’s or Master’s degree in Chemistry, Biochemistry, Microbiology, Biotechnology, Pharmacy, or related scientific field.
- 5+ years QC experience in GMP aseptic manufacturing.
- Relevant certifications (e.g., GMP, CAPA, Regulatory Affairs) are advantageous.
Nouvelle-aquitaine, France
Hybrid
Mid level
04-02-2026