Compliance Specialist Senior

Job title: Compliance Specialist Senior

Location: Ridgefield, NJ

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.

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, and animal health.

The Compliance Specialist will be responsible for leading root cause analysis activities, approving deviations reports and providing technical support to Operations. In addition, this role will be responsible for creation, review and approval of CAPAs and Effectiveness Checks.

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?

Main Responsibilities:

• Collaborate with Quality, Subject Matter Experts (SME) and Manufacturing as required; determine the scope of the investigation.
• Leading and authoring investigations (and investigation team) to ensure regulatory compliance
• Develop investigation strategy and complete within required timeline
• Proficient in understanding Root Cause Analysis Techniques
• Classification, review, and approval of deviations
• Support investigations of minor non-conformances
• Present investigation to Management Review Board
• Creation and approval of CAPAs to ensure Root Cause is properly addressed
• Trending of deviation and CAPA reports, and recommendations per results
• Communicate complex issues concisely

HSE

• It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.

• The individual must support all Sanofi and site HSE policies as well as ensure that work performed is compliant with local HSE regulations.

• Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.

About You

Education / Experience:

• Bachelor's Degree with 3 or more years’ experience completed deviations or in a QA Environment

• Working knowledge of cGMPs in pharmaceuticals/biological and aseptic manufacturing

• Excellent technical writing skills

• Leading Investigation Team

• Strong analytical and problem-solving skills

• Make sound judgement from data

• Strong communicator

• Works independently to ensure on-time investigation closure

• Working knowledge of Word, Excel, PowerPoint

• Preferred experience with Lean, 5S and Gemba for CAPA

• Preferred experience with a deviation/CAPA enterprise systems

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 your