Audit and Inspection Manager - GxP

Job Title: Audit and Inspection Manager

Location: Framingham, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for 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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main 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

Key involvement in Decision Making process

• 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)

About You

Requirements/Qualifications

• 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 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

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 a 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. 

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.

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