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. #J-18808-Ljbffr Scorpion Therapeutics