Audit And Inspection Manager - Gxp

5+ years

USD 84,750.00 - 141,250.00

Massachusetts

10 Oct. 28, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧾 Job Title: Audit and Inspection Manager – GxP

📍 Location: Framingham, Massachusetts, USA
💰 Salary Range: USD 84,750.00 – 141,250.00
🏢 Company: Sanofi
🔗 Application: [Apply Now]

🧭 About the Company

Sanofi is a global healthcare innovator delivering over 4 billion units of medicines and vaccines annually.
Through advanced manufacturing, automation, and AI-driven facilities, Sanofi ensures that treatments reach patients faster, safer, and more sustainably.
Our mission is clear — to chase the miracles of science to improve people’s lives.

💼 About the Role

The Audit and Inspection Manager – GxP is responsible for leading and managing internal audits, external regulatory inspections, and inspection readiness programs across Sanofi’s operations.
This role ensures compliance with GxP (Good Practice) standards, drives continuous improvement, and maintains a state of inspection readiness in line with global quality expectations.

⚙️ Key Responsibilities

Audit & Inspection Management

Develop and implement an annual self-inspection plan based on risk assessment.
Review internal audit reports before submission to ensure accuracy and consistency.
Ensure an inspection readiness system is maintained for both announced and unannounced inspections.
Lead and coordinate regulatory inspections and internal audits from planning to closure.

Compliance & Corrective Actions

Identify inspection “near misses” and recommend corrective/preventive measures.
Contribute to formal inspection responses and regulatory correspondence.
Monitor implementation and timely closure of CAPAs (Corrective and Preventive Actions).

Leadership & Team Oversight

Manage and mentor the audit and inspection team, ensuring ongoing training and qualification.
Represent the site in the Community of Practice (CoP) and potentially in the Center of Excellence (CoE) for quality.
Participate in strategic decision-making and risk mitigation related to compliance.

Communication & Collaboration

Liaise effectively with cross-functional teams and senior management to communicate audit outcomes.
Advise departments on compliance gaps and assist in developing robust corrective actions.
Track CAPA implementation and provide status updates to stakeholders.

🎓 Qualifications & Experience

Required:

Bachelor’s degree in Biological Sciences or a related discipline (preferred).
5+ years of experience managing internal audits and regulatory inspections in the pharmaceutical/biotech industry.
Strong knowledge of GxP regulations (GMP, GLP, GCP) and other applicable quality standards.
Proven ability to manage multiple audits and inspections simultaneously.
Excellent written and verbal communication skills.
Strong analytical and organizational abilities to interpret complex audit data and findings.

Preferred:

Experience interacting directly with regulatory agencies (e.g., FDA, EMA, MHRA).
Familiarity with risk-based audit scheduling and quality management systems.

🌍 Why Join Sanofi

Be part of a future-focused, global team dedicated to advancing human health.
Access career development opportunities — promotions, international roles, and cross-functional mobility.
Enjoy a comprehensive benefits package, including:
- High-quality healthcare coverage
- Wellness and prevention programs
- 14 weeks of gender-neutral parental leave
- Recognition-based rewards and bonuses

⚖️ Equal Opportunity Statement

Sanofi and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to diversity and inclusion.
All qualified applicants will receive consideration for employment without discrimination based on race, color, religion, national origin, gender, sexual orientation, disability, veteran status, or any protected characteristic under applicable law.

🔖 Job Category:

Quality Assurance (QA) / Compliance / GxP Auditing – Pharmaceutical Manufacturing

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Audit And Inspection Manager - Gxp

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