GLP and GCLP Compliance Expert

Sanofi; Swiftwater (Monroe County); On-site; USD 110,000 - 160,000; Full time

Job summary

Sanofi is seeking a GLP and GCLP Compliance Expert to support global R&D vaccine programs. You will establish a quality audit program, oversee external partnerships, and ensure regulatory compliance across GLP, GCLP and related activities.

The role requires extensive cross-functional collaboration, willingness to travel ~30%, and the ability to work independently in a fast-paced, global environment to protect patient safety.

Qualifications

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

Responsibilities

• GLP Compliance: Partner with R&D to embed GLP throughout the test item lifecycle.
• Oversee GLP activities ensuring items are manufactured, characterized and documented.
• Provide guidance on GLP requirements for study design, conduct and reporting.
• GCLP Compliance: Develop and implement a GCLP-aligned QMS for clinical endpoints.
• Support trial teams in lab selection, qualification and oversight.
• Ensure data integrity, traceability and regulatory compliance in labs.
• Participate in self-inspection audits and activities.
• External Partner Oversight: Audit CROs, labs and third parties for GxP compliance.
• Develop risk-based audit plans; oversee CAPA implementation and resolution.
• Address non-conformances and corrective actions with external partners.
• Serve as primary quality interface with external labs.
• Perform due diligence and assist integration of new entities as needed.
• Global Leadership & Communication: Train stakeholders on GLP/GCLP knowledge.
• Collaborate with R&D, Clinical, Regulatory and Quality across geographies.
• Operate independently across time zones; represent Sanofi in regulatory forums.

Skills

GLP/GCLP compliance

Audits & oversight

Regulatory knowledge

Cross-cultural communication

Autonomy & strategy

Education

Bachelor's degree in Life Sciences/Pharmacy

Job description

Job Title: GLP and GCLP Compliance Expert

• Location: Swiftwater, PA

About Job

The R&D GLP & GCLP Compliance Expert position is globally responsible for support to internal and external nonclinical GLP and GCLP activities within Sanofi R&D Vaccines to ensure compliance with applicable regulatory standards, industry guidance and Sanofi requirements. The incumbent will establish organization objectives for the R&D vaccine GLP and GCLP Quality Audit Program and ensure independent quality oversight of Sanofi – sponsored clinical trial analytical testing in accordance with GCP requirements and GCLP industry guidance.

This position supports R&D teams across the full vaccine portfolio, managing activity with both internal and external partners. The ability to build strong, trust-based relationships across functions and geographies is essential to drive resolution of issues with urgency and integrity and ensure the safety and needs of patients. Applying sound judgement in balancing Quality requirements with business needs is essential, as it adapting to evolving organizational priorities. The incumbent must be able to operate independently day-to-day with a minimum of supervision.

Join the team protecting half a billion lives every year with next-gen science, mRNA innovation, and AI driven breakthroughs. In Vaccines, you’ll help advance prevention on a global scale - and shape the future of immunization.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

About You

Basic Qualifications

• 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%).

Preferred Qualifications

• Masters or PhD
• Proven ability to communicate effectively across cultures, functions, and seniority levels.
• High degree of autonomy, strategic thinking, and problem-solving capability.

Main Responsibilities

GLP Compliance:

• 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.

GCLP Compliance

• 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.

External Partner Oversight

• 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.

Global Leadership & Communication

• 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.

HSE Requirement

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

Why Choose Us

• 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.

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.