GLP and GCLP Compliance Expert - Vaccine

Qualifications / Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, or related discipline.
- 3+ years’ experience in GLP/GCLP compliance within pharmaceutical or biotech R&D.
- Strong knowledge of global regulatory frameworks (FDA, EMA, OECD, ICH).
- 3+ years’ experience leading audits and managing external partners.
- Willingness to travel internationally (~30%).

Preferred Qualifications
- Master’s or PhD.
- Proven ability to communicate effectively across cultures, functions, and seniority levels.
- High degree of autonomy, strategic thinking, and problem-solving capability.

Responsibilities
- Embed GLP principles across the test item lifecycle; oversee GLP-related manufacturing, characterization, and documentation.
- Provide expert guidance on GLP requirements for study design, conduct, and reporting.
- Develop and implement a GCLP-aligned QMS for clinical laboratory endpoints.
- Support clinical development teams with laboratory selection, qualification, and oversight; ensure data integrity, traceability, and regulatory compliance.
- Lead and manage audits of CROs, laboratories, and other third parties for GxP compliance; execute risk-based audit plans and oversee CAPA.
- Handle non-conformances and corrective actions for external parties; act as primary quality interface with external laboratories.
- Train internal stakeholders and collaborate with R&D, Clinical, Regulatory, and Quality teams.

Benefits (if applicable)
- Health and wellbeing benefits, including at least 14 weeks’ gender-neutral parental leave.