Principal Compliance Specialist, QA Operations

Job Title: Principal Compliance Specialist, Operations

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. 

Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi's Framingham Biologics facilities.  QA's main responsibility is to ensure cGMPs are adhered to during manufacturing operations.  Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality and efficacy of Sanofi’s 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 Principal Compliance Specialist is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP.  The Principal Compliance Specialist may also be responsible for providing leadership to the QA team in the absence of the manager. 

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Working hours: Monday-Friday, first shift.  Shift of 7A – 7P, with rotating weekends also available.

Main Responsibilities:

• Provide Gemba Support
• Function as shift lead including developing junior employees
• Perform batch record review
• Perform review of column packing and qualification records
• Review and sign-off on manufacturing supervisor notes
• Review and approve CRs related to EBRs (as applicable)
• Function as SME on challenges related to production requiring a quality input
• Non-conforming material discard
• Perform logbook review
• Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps
• Issue action notices and conduct affiliated provisional release
• Conduct logbook audits against compliance requirements
• Review CV related documentation against specification
• Perform Bulk Raw Material Release
• Perform media / buffer and intermediate release
• Perform release of Cell Banks for forward processing (as applicable)
• Support cross-functional internal audit activities and conduct walkthrough inspections.
• Function as department lead for internal audits
• Function as CAPA owner
• Execute containment activities
• 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 manufacturing and support operations to ensure a culture of continuous compliance.
• May provide training to new employees
• Review of Quality Critical Alarms and NRSR
• Initiate and investigate and QA review deviations
• Provide off-hour support for batch record and logbook issuance
• Represent for QA Ops for various projects (e.g. CCR FMEA, Risk Assessment, RCA).
• Function as back-up for QA Manager
• 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.

About you

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services. 

This includes:

• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Sanofi a great place to work and a company respected for the quality of its people and products.
• Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.  
• Coaching and mentoring QA personnel including QA Ops customers
• Flexible and adaptable to changes and support business needs

Basic Qualifications:

• High School Diploma with 10+ years of experience in a Quality and /or other CGMP related field - required. 
• 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 Trackwise, Veeva, or equivalent system.
• Proficient in Microsoft Office.

Preferred Qualifications:

• Associate’s degree with 8+ years of experience or Bachelor’s degree with 6+ years of experience or Master’s degree with 4+ years of experience in a Quality and / or cGMP environment – preferred.
• 4+ years’ experience in a Quality Assurance 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. 

Special Working Conditions:

• Ability to gown and gain entry to manufacturing areas
• Ability to work a 12-hour rotating shift and every other weekend, including some holidays as needed
• Ability to lift 10 lbs.

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 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 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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