GLP and GCLP Compliance Expert

GLP and GCLP Compliance Expert

• Location: Swiftwater, PA

• Bachelor's degree in Life Sciences, Pharmacy, or related discipline.

• 3+ years of experience in GLP/GCLP compliance within pharmaceutical or biotech R&D.

• Strong knowledge of global regulatory frameworks (FDA, EMA, OECD, ICH).

• 3+ years of experience leading audits and managing external partners.

• Willingness to travel internationally (~30%).

• Masters or PhD

• Proven ability to communicate effectively across cultures, functions, and seniority levels.

• High degree of autonomy, strategic thinking, and problem-solving capability.

• Partner with R&D stakeholders to embed GLP principles throughout the test item lifecycle.

• Oversee GLP-related activities ensuring test items are appropriately manufactured, characterized, and documented.

• Provide expert guidance on GLP requirements for study design, conduct, and reporting.

• Lead the development and implementation of a GCLP-aligned QMS for clinical laboratory endpoints.

• Support clinical development teams in laboratory selection, qualification, and oversight.

• Ensure data integrity, traceability, and regulatory compliance in clinical laboratory operations.

• Participation and support of self-inspection audits and activities.

• Conduct and manage audits of CROs, laboratories, and other third parties to ensure GxP compliance.

• Develop and execute risk-based audit plans; oversee CAPA implementation and resolution.

• Deal with non-conformances and follow corrective actions of external Third parties.

• Act as the primary quality interface with external laboratory partners.

• Performs due diligence activities and assists with the integration of newly acquired entities, as needed.

• Train and educate internal stakeholders with respect to current GLP. GCLP needs.

• Work with NV Project Teams to assess and resolve items related to GLP or GCLP topics or noncompliance events.

• Collaborate effectively with cross-functional teams including R&D, Clinical, Regulatory, and Quality.

• Operate independently across multiple geographies and time zones. Represent the company in regulatory interactions, industry forums, and external engagements.

• Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

• Work at the forefront of AI-driven research, smart manufacturing, and groundbreaking mRNA platforms that are redefining the future of immunology.

• Help protect half a billion people every year, contributing to one of the largest global vaccination efforts in healthcare.

• Be part of a company that believes in the future with significant investment annually in manufacturing innovation.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SP #LI-SP #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.