Sanofi US
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.
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.
Work Schedule 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 in 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
Proficient in scheduling and coordination utilizing GoGemba tool
Proficient in Microsoft Excel; experience with SharePoint and Microsoft Teams
Problem‑solving and troubleshooting abilities
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 Affirmissive 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; 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.
The salary range for this position is: $67,500.00 - $97,500.00
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.
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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.
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.
Work Schedule 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 in 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
Proficient in scheduling and coordination utilizing GoGemba tool
Proficient in Microsoft Excel; experience with SharePoint and Microsoft Teams
Problem‑solving and troubleshooting abilities
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 Affirmissive 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; 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.
The salary range for this position is: $67,500.00 - $97,500.00
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.
#J-18808-Ljbffr