Audit and Inspection Manager - GxP

About The Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the meticulous planning and attention to detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Job Title: Audit and Inspection Manager

Location: Framingham, MA

• Developing and implementing an annual self-inspection plan
• Reviewing 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 outcomes 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, may 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
• Advise on corrective actions for identified non-compliance issues
• Track and inform relevant stakeholders about the status of CAPA implementation

• Bachelor's degree in Biological Sciences or related field - preferred
• 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 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 GMP and other relevant guidelines

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Grow your talent and career through promotions or lateral moves, at home or internationally.
• Receive a thoughtful rewards package that recognizes your contribution and amplifies your impact.
• Access health and wellbeing benefits, including healthcare, prevention and wellness programs, and parental leave.

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 any other characteristic protected by law.

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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.