Sanofi Group Principal Compliance Specialist in Framingham, Massachusetts
The Principal Compliance Specialist is responsible for providing quality support and guidance to manufacturing, Quality Control and support functions to ensure continued compliance to cGMP. The Principal Compliance Specialist may also be responsible for providing leadership to the Quality team in the absence of the manager.
Core Responsibilities Include:
Provide Gemba Support
Including developing junior employees
Perform record review
Function as SME on challenges related to operations requiring a quality input
Perform log book review
Provide on the floor (OTF) support to the operations department
Conduct log book audits against compliance requirements
Support cross-functional internal audit activities and conduct walkthrough inspections
Function as CAPA owner
Provide expertise during procedure/SOP revision process and function as DCR approver for department related SOPs and PRs
Function as document owner as needed
Maintain a high level of personal compliance to the required standards
Partner with operations to ensure a culture of continuous compliance
May provide training to new employees
Support deviations and investigation
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.
Master's Degree & 4 years of experience, Bachelor’s Degree and 6 years of experience, Associate's Degree and 8 years of experience, or a High School Diploma and 10 years of experience in a Quality and /or other CGMP related field.
2 years of experience in a Quality role.
Working experience in external agency regulatory audits (FDA, EMA, etc.).
Demonstrated experience guiding others through Quality Systems such as Deviations, CAPAs, Investigations.
Prior experience leading teams or projects.
Knowledge in external agency regulations (FDA, EMA, etc.)
Strong computer, verbal and written communication skills.
Experience in quality systems.
Experience in leading cross functional teams.
Experience with Phenix or equivalent system.
Proficient in Microsoft Office.
Bachelor’s degree in a scientific field with 6+ years of experience in a Quality and / or cGMP environment.
4+ year’s experience in a Quality role.
Experience in bio-pharmaceutical industry.
Capable of analyzing trends and metrics that lead to improvement.
Strong technical writing skills.
Effective time management, attention to detail, organizational skills, teamwork and collaboration.
Significant capability in problem solving methodology.
Experience working in an environment of operational excellence.
Experience training and developing employees.
Experience participating in external agency inspections.
Knowledge of regulatory enforcement trends.
Ability to work independently.
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.
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.