Quality Compliance Specialist
QA Compliance Expert – GMP Self-Inspections & Data Integrity (Neuchâtel, Switzerland)
CK QLS are seeking a QA Compliance Expert to join the Quality Compliance & Systems team at our clients Neuchâtel site.
- Reporting to the Head of Quality Compliance & Systems, this role is responsible for the site Quality System related to GMP self-inspections, inspection readiness, data integrity, and selected quality improvement initiatives.
- You will work closely with cross-functional teams to ensure compliance with internal standards and regulatory expectations and contribute to continuous improvement.
- Lead the risk-based GMP self-inspection program (planning, execution, follow-up) and support lead auditors.
- Coach SMEs and audit teams to strengthen inspection readiness.
- Support internal/external audits and mock audits.
- Perform gap assessments for new/revised procedures and ensure site alignment.
- Act as the local Data Integrity champion in collaboration with global teams.
- Prepare and present compliance topics to site governance forums and drive continuous improvement.
- University degree in a scientific/technical discipline (or equivalent).
- Minimum 7 years’ experience in biotech and/or pharmaceutical industry; strong GMP expertise.
- Strong understanding of GDDP and data integrity principles.
- Experience with SOP/technical documentation and regulatory inspections/audits.
- Familiarity with risk management tools (e.g., FMEA, root cause analysis).
- French and English proficiency (minimum B2).
- Experience with eQMS (e.g., Veeva Vault, TrackWise), MS Office, and Power BI.
To apply, please contact Rob Angrave or Adrien Guimard on info@ckqls.ch or call +41 444 990468.