Sanofi · 2 days ago
Audit and Inspection Manager - GxP
Framingham, MA
Full-time
Onsite
Senior Level
$90K/yr - $150K/yr
5+ years expSanofi is an innovative global healthcare company dedicated to improving people's lives through science. They are seeking an Audit and Inspection Manager to develop and implement self-inspection plans, manage regulatory inspections, and ensure compliance with pharmaceutical regulations.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Developing and implementing an annual self-inspection plan
Reviewing the internal audit reports before submission to senior management to ensure accuracy and consistency
Ensuring an inspection readiness process is in place to manage announced and unannounced inspections
Leading and managing regulatory inspections and audits
Identifying near misses during inspections and recommending corrective actions
Reviewing inspection outcome and contributing to the answers
Monitoring the implementation of corrective and preventive actions (CAPAs) related to audit and inspection
Managing the audit and inspection team and ensuring their proper qualification for their activity
Representing the site in the CoP, could be a member of the CoE, and ensuring local communication
Decide on the structure and timing of internal audit plans and schedules, based on risk assessment (D)
Advise on corrective actions for identified non-compliance issues (A)
Track and inform relevant stakeholders about the status of CAPA implementation (I)
Qualification
Required
5+ years of experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow-up
Ability to analyze complex data and audit findings to identify compliance issues and recommend corrective actions
Meticulous attention to detail to ensure accuracy in audit reports, documentation, and compliance assessments
Strong verbal and written communication skills to effectively liaise with regulatory bodies, present findings to senior management, and train staff
Proficiency in managing multiple audits and inspections simultaneously, including planning, scheduling, and coordinating with various departments
In-depth understanding of pharmaceutical regulations and standards, including Good Manufacturing Practices (GMP) and other relevant guidelines
Preferred
Bachelor's degree in Biological Sciences or related field
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-06
BioWorld Financial Watch
2026-01-06
2026-01-06
Company data provided by crunchbase