Sanofi Group Compliance Specialist, Framingham, MA in Framingham, Massachusetts

Department Description:

The Quality organization supports the HA/CMC, Seprafilm (medical device), Analyze Specific Reagents, (ASRS) and Sodium Hyaluronate (active pharmaceutical ingredient) GMP operations at the Genzyme 74/76 NYA Manufacturing facility. The organization supports the employees that comprise the site’s Quality Assurance, Quality Control, Quality Engineering, Manufacturing Technical support and Materials Management organizations.

Position Overview with Key Responsibilities:

Position Summary

This position will report to the Quality Supervisor / Manager and will assist in maintaining the quality systems and GMP compliance in support of ongoing operations at the Biosurgery manufacturing site.

Core Responsibilities

Compliance Specialist duties will include but not be limited to:

  • Perform all aspects of lot issuance, lot review/release process, ensuring compliance to the relevant site release SOP and corporate standard.

  • Perform review of testing results in support of release of intermediates.

  • Participate in investigation of all lot-associated deviations, change controls (CCR/LCR), Building Management System (BMS) investigations, action notices and environmental excursions as required.

  • Perform QA presence on the floor (oversight or AQL, as appropriate).

  • Perform various QMS trending/reporting functions.

  • Perform monthly compliance walkthroughs and review status of pest control logs.

  • Ensure compliance to the relevant SOP and corporate standards.

  • Lead/Participate in investigation of non-lot associated deviations, change controls (CCR/LCR), Building Management System (BMS/EMS) Investigations, action notices and environmental excursions as required.

  • Serve as site SME for at least one major quality system element, for example: Customer complaints, deviations/CAPA and EM.

  • Write and complete analysis of above investigation (s), identify issues and provide recommendations for improvements.

  • Participate in monthly walkthrough program and review pest control logs.

  • Manage assigned site QA projects.

  • Ensure that documentation and operations meet established requirements of cGMPs, Internal SOPs and company policies.

  • Draft and revise procedures (DCR) as required.

  • Serve as an internal auditor for the Biosurgery operation.

  • Perform various QMS trending/reporting functions, FMEA/risk team member as appropriate.

  • Actively participate in the preparation, execution and follow-up for audits from regulatory agencies, notified bodies, customers and Global Quality Auditors.

  • FMEA/Risk team member as appropriate.

  • May represent organization/group as a prime contact on project teams.

  • May serve as team leader for continuous improvement teams or investigative teams.

Basic Qualifications:

Bachelor's Degree & 3 years' of experience OR

Associate's Degree & 5 years of experience in Quality or cGMP operations.

Preferred Qualifications:

  • Bachelor’s Degree in a scientific discipline or equivalent with 4-6 years industry experience in quality or operations including experience in cGMP, pharmaceutical/medical device quality systems.

  • Strong technical background in regulated products.

  • Excellent communication skills both written and verbal.

  • Strong critical thinking ability.

  • Effective time management and organizational skills.

  • Strong attention to detail and ability to work with others in a group environment

Special Working Conditions:

Ability to gown and enter clean rooms

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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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

At Sanofi diversity and inclusion are foundational to how we operate and are embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize that to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life