Operations Compliance Engineer Senior

Job Title: Operations Compliance Engineer

Location: Northborough, 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.

The Operations Compliance Engineer Senior is responsible for the daily activities at the Northborough facility, in partnership with his/her team and peers, to achieve business objectives aligned with site priorities.

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:

• Work cross-functionally with subject matter experts to update and develop procedures across the entire site.

• Cooperates transversally to investigate and resolve distribution related customer (both internal and external) complaints.

• Use ERP systems to collect supply chain data to support investigations and recall management.

• Support department for internal and external audits.

• Uses Sanofi compliance enterprise systems to initiate and complete deviation investigations, CAPAs and related tasks.

• Works cross-functionally with SMEs to develop, initiate and manage change controls.

• Participates and develops metrics for Quality Council Meetings.

• Represents department as SME for meetings.

• Trains and mentor's department team members.

• Delegate for department manager duties.

• Works across Sanofi network to share best practices and participate in communities of practice.

• Facilitates deviation investigation meetings with SMEs to complete root cause analysis and identify corrective and preventative actions.

• Facilitates daily metric discussions at the Gemba to include KPI's, trending, and pareto analysis of daily business drivers.

• Recommends and develops ideas for improvement in operating methods and procedures to resolve problems prior to or when they arise.

About You

Basic Qualifications

• High school diploma / GED with minimum 10-15 years' experience (or)

• Bachelor’s degree and minimum 5-8 years' experience working in a Biopharma regulated cGMP environment. Excellent interpersonal skills.

• Experience performing/facilitating risk assessments (REM, Comparison Matrix, FMEA, etc.).

• Lean / Six Sigma experience required.

• Participation in external cGMP regulatory audits.

• Experience using root cause analysis tools (5 Why’s, Ishikawa/Fishbone, etc.).

• Strong Deviation, CAPA, Change Control, SOP writing experience required.

• Solid working knowledge of MS Office (Word/Excel/PowerPoint).

Preferred Qualifications

• Bachelor’s degree in science or engineering related fields.

• Master's degree in related field.

• Experience using graphic design software to create and edit graphics and videos.

• Experience creating workspaces using Sharepoint.

• Experience representing site in global cross-functional teams.

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 sta