Operations Compliance Engineer

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 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.

• Demonstrated ability to dissect a problem, understand the stakeholders and bring them to the table, collect the right data and present it in a way to effectively describe the right problem to solve, and skills needed to facilitate.

• challenging discussions to identify the best solution to implement to eliminate the problem.

• 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.

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

• Facilitates in 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.

• Strong project and program management skills. Able to mentor/teach others.

• Effective at providing feedback to peers inside and outside of direct organization

About You

Basic Qualifications

• High school diploma / GED with minimum 8 -10 years' experience (or) bachelor’s degree and minimum 3-5 years' experience working in a Biopharma regulated cGMP environment.

• Excellent interpersonal and meeting/workshop facilitating skills

• Experience participating in risk assessments (REM, Comparison Matrix, FMEA, etc.).

• SMS / Lean / Six Sigma Experience required.

• Deep understanding of root cause analysis tools (GPS, Ishikawa/Fishbone, etc.) Deviation, CAPA, Change Control, SOP writing experience required.

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

• Project and Program Management experience required.

Preferred Qualifications

• Bachelor’s degree in science or engineering related fields

• PMP certification and/or master's degree.

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

• Participation in external cGMP regulatory audits.

• Experience creating workspaces using SharePoint.

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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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

North America Applicants Only

The salary range for this position is:

$74,250.00 - $107,250.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.