Sanofi Group Principal Compliance Specialist in Framingham, Massachusetts

his 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.Principal Compliance Specialist duties will include but not be limited to:

Perform all aspects of lot issuance, lot review and 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.

Assume leadership role in the training of new employees.

Participate as site SME on Community of Practice Teams.

Investigate quality critical alarms.

Assist in the development of Quality Technical Agreements (QTA).

Performs work that requires decision making and the consistent exercise of independent judgment and discretion.

Perform Quality Assurance review for deviations, investigations, DCRs and complaints and manage associated files.

Review and approve SOP revisions in accordance with regulatory filings and regulations.

Review and approve Validation protocols and technical reports as appropriate.

Assist in the oversight of the sterility assurance program.

This role may be trained and designated for release of intermediate products for release at the site.

Basic Qualifications

Master's Degree & 4 years of experience OR Bachelor's Degree & 7 years of experience OR Associate's & 9 years of experience Master’s Degree and 8 or more years experience in cGMP.

Preferred Qualifications

Strong technical background in regulated products.

Excellent communications skills both written and verbal.

Strong critical thinking ability. Strong leadership ability.

Effective time management and organizational skills.

Strong attention to detail and ability to lead others in a team setting.

Special Working Conditions

Ability to gown and enter clean rooms

Sanofi Genzyme, the specialty care business unit of Sanofi, focuses on rare diseases, multiple sclerosis, oncology, and immunology. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. Our approach is shaped by our experience developing highly specialized treatments and forging close relationships with physician and patient communities. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world. Learn more at www.sanofigenzyme.com.

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare.

Genzyme Corporation (a Sanofi company) 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.

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

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