GLP and GCLP Compliance Expert - Vaccine

Sanofi Group; Pennsylvania; Hybrid; USD 113,000 - 164,000; Full time

Benefits offered by this job

Health benefits

Parental leave (14 weeks)

Job summary

Sanofi seeks a GLP and GCLP Compliance Expert in Swiftwater, PA to support nonclinical GLP/GCLP activities across R&D Vaccines and ensure regulatory alignment.

You will lead audits of CROs and labs, oversee data integrity, and collaborate with cross‑functional teams globally while traveling ~30% to maintain compliance and drive patient safety in vaccines.

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.

Responsibilities

• Partner with R&D to embed GLP principles throughout the test item lifecycle.
• Oversee GLP-related activities ensuring test items are manufactured, characterized, and documented.
• Lead development and implementation of a GCLP-aligned QMS for clinical endpoints.

Skills

GLP/GCLP compliance

Auditing leadership

Regulatory knowledge (FDA EMA ICH)

Cross-cultural communication

Travel readiness

Education

Bachelor's degree in Life Sciences/Pharmacy or related

Masters or PhD

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.
• Perform 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 Affdenative 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.

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affdenative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

North America Applicants Only

The salary range for this position is: $113.250,00 - $163.583,33All compensation will be determined commensurate with demonstrated experience.Employees may be eligible to participate in Company employee benefit programs.Additional benefits information can be found through the LINK.

Wir sind ein forschendes Biopharma-Unternehmen, das KI anwendet und sich dafür einsetzt, das Leben der Menschen zu verbessern und verantwortungsvoll zu wachsen. Unser Team wird von einem Ziel geleitet: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern. Wir möchten eine gesündere, widerstandsfähigere Welt schaffen und das Unmögliche möglich machen, indem wir Medikamente und Impfstoffe für Millionen von Menschen weltweit entdecken, entwickeln und bereitstellen. Erfahren Sie mehr über uns auf www.sanofi.com oder schauen Sie sich unseren Film an: We are Sanofi Starte eine Karriere, die einen Unterschied macht. Neuerfindung liegt in unserer DNA. Sie hat unsere Entwicklung von einem kleinen französischen Unternehmen zu einem der weltweit führenden Biopharma-Unternehmen vorangetrieben. Ob es darum geht, KI zu nutzen, um die Zeiten der Arzneimittelforschung aufzubessern, oder Vertrauen im Gesundheitswesen aufzubauen – du kannst unseren Teams dabei helfen, das Leben für Patient*innen, Partner*innen und Gemeinschaften zu verbessern. Here entwickelst du deine Karriere weiter. Wir öffnen dir die Tür, um neue Möglichkeiten zu entdecken, deine Grenzen zu erweitern und dich mit Menschen zu vernetzen, die von einem gemeinsamen Ziel angetrieben werden: Wir erforschen die Wunder der Wissenschaft, um das Leben der Menschen zu verbessern.