Senior Compliance Specialist

The Biosurgery Quality Assurance (QA) department is responsible for quality oversight of operations at the Sanofi Framingham Biosurgery facility. Biosurgery QA’s primary responsibility is to ensure adherence to cGMPs during manufacturing operations through partnership with the site and direct engagement with daily operations activities. Biosurgery QA is responsible for providing support and guidance to the Biosurgery Operations function in order to protect the safety, quality and efficacy of Sanofi medical device products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company’s business and global markets.

The Senior Compliance Specialist is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMPs.

The Senior Compliance Specialist is also responsible for mentoring and coaching junior staff.

Core Responsibilities include but not limited to:

• Perform batch record review

• Perform quality inspections of intermediates and finished goods.

• Provide on the floor (OTF) support to the operations department, including OTF support for critical operations

• Assess Building Management System (EMS) alarms and investigations

• Initiate, investigate and perform QA review of deviations

• Execute containment activities

• Approve and Release action notices

• Support internal audit preparation activities as well as cross-functional internal audit activities and conduct walk-through inspections

• Provide gemba support

• Review NRSRs (Non-Routine Sample Requests)

• Function as SME on input to quality decisions

• Partner with manufacturing and support operations to ensure a culture of continuous compliance

• Provide training to new employees

• Revise procedures/SOPs

• Approve non-conforming material discards

• Other activities as assigned

Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.

Basic Qualifications:

• Bachelor’s Degree in a scientific discipline and 4 years of related experience, Associate's Degree and 6 years of related experience or High School Diploma and 8 years of related experience in a Quality and /or other CGMP related field

• Bachelor’s degree in a non-scientific field with 6 years of related experience in a Quality and/or cGMP environment.

• Basic to Intermediate computer proficiency, strong verbal and written communication skills.

• Experience with quality systems and cGMP data review.

Preferred Qualifications:

• Bachelor’s degree in a scientific field with 4 years of experience in a Quality and / or cGMP environment.

• Experience in the medical device or bio-pharmaceutical industry.

• Strong technical writing skills

• Effective time management, attention to detail, organizational skills, teamwork and collaborations.

• Demonstrated competence in problem solving methodology.

• Experience participating and/or leading cross-functional project team collaborations.

Special Working Conditions:

• Ability to gown and enter clean rooms

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

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.

#GD-SG
#LI-GZ

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize 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 colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.