Compliance Specialist - Gemba/GMP

Job Title: Compliance Specialist

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. 

Our Team/Overview: The GoGemba GMP Walkthrough Program team is responsible for ensuring compliance with Good Manufacturing Practices (GMP) across the organization through systematic walkthroughs. Our mission is to maintain high quality standards and drive continuous improvement in our manufacturing processes.

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?

**Onsite 5 days a week to start then will transition to hybrid 3 days per week - required. **

Main Responsibilities:

• Contributing to the development and maintenance of an effective compliance program

• Ensuring all operations comply with relevant regulatory requirements and other international standards

• Providing training and guidance to employees on compliance-related topics

• Maintaining compliance-related documentation, ensuring accuracy and completeness

• Identifying potential compliance risks and contributing to the development of strategies to mitigate them

• Supporting the investigation and reporting of compliance incidents

• Managing CAPA to address compliance incidents and preventing recurrence

• Contributing to continuous improvement initiatives to enhance compliance processes and systems

• Preparing and participating in internal and external audits and regulatory inspections

• Organize/optimize the GMP walkthrough process across the organization using the GoGemba system

• Participate as the primary coordinator between area owners, quality teams, and upper management

• Schedule and coordinate all GMP walkthroughs in the GoGemba system

• Communicate the walkthrough planning tool (Excel) on the Teams channel

• Monitor walkthrough completion status and follow up on outstanding items

• Provide technical support and troubleshooting for GoGemba system users

• Track and report KPIs and metrics to upper management

• Identify continuous improvement initiatives for the walkthrough program

• Gather participant feedback to enhance program effectiveness

• Update standard operating procedures (SOPs) as needed

• Collaborate with GoGemba Admin to implement system improvements

Key Involvement in Decision Making Process

• Support management on compliance topics

• Review the relevance of remediation action from findings from internal and external audits related to health-related topics

• Advise on improvements to compliance processes and systems

• Advise on risk mitigation strategies

• Advise on corrective actions for compliance incidents

• Advise on continuous improvement initiatives

• Coordinate quality alert and batch recall process with global team

• Decide on walkthrough schedules and coordination strategies

About You

Education & Experience:

• BS - Pharmaceutical Sciences, Chemistry, Biology, or a related scientific discipline – preferred. 
• 2+ years of relevant experience in the pharmaceutical or healthcare industry.
• Additional certifications in Quality Management Systems or Regulatory Compliance would be beneficial.

Skills & Qualifications:

• In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH)

• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions

• Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders

• Proficiency in managing multiple compliance projects simultaneously, ensuring timely completion and adherence to standards

• Keen attention to detail to ensure accuracy in compliance documentation, audits, and reports

• Strong communication skills (written and verbal)

• Proficient in scheduling and coordination utilizing GoGemba tool

• Proficient in Microsoft Excel - Experience with SharePoint and Microsoft Teams

•  Problem-solving and troubleshooting abilities  

• Attention to detail and follow-through  

• Ability to work with cross-functional teams

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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Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative 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:

All 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.