
Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden
Operations Compliance Engineer Senior
Auf einen Blick:
Unsere Teams produzieren und liefern jedes Jahr über 4 Milliarden Einheiten an Medikamenten und Impfstoffen und sorgen dafür, dass jede Innovation die Menschen erreicht, die sie am dringendsten benötigen. Unsere hochmodernen Produktionsstätten, KI-gestützten Smart Factories und wegweisenden Automatisierungstechnologien setzen neue Maßstäbe – damit Behandlungen Patient*innen schneller, sicherer und nachhaltiger als je zuvor erreichen. Hier kannst Du mit Deinen Fähigkeiten, Deinen Ambitionen und Deiner Leidenschaft die Zukunft des Gesundheitswesens mitgestalten.
Job Title: Operations Compliance Engineer Senior
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 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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Mehr Informationen über diesen Standort

Warum bei uns arbeiten?
- Wir stellen nicht nur Medikamente her – wir bewirken etwas. Unser globales Netzwerk modernster Produktionsstätten sorgt dafür, dass Patient*innen die Behandlungen erhalten, die sie brauchen – genau zur richtigen Zeit.
- Innovation treibt uns an. Von KI-gestützter Fertigung bis hin zu weltweit führenden Produktionsmethoden setzen wir neue Maßstäbe in Effizienz und Leistung.
- Hier wachsen Karrieren. Ob in der Produktion, Qualitätssicherung, Ingenieurtechnik oder in der Supply Chain– arbeitest Du mit erstklassigen Talenten zusammen, entwickelst Deine Fähigkeiten weiter und gestaltest die Zukunft der Pharmaindustrie mit.
- Wir tun, was richtig ist. Sicherheit, Nachhaltigkeit, Vielfalt, Gleichberechtigung und Inklusion stehen im Mittelpunkt unseres Handelns – für ein Arbeitsumfeld, in dem alle erfolgreich sein können.
All-In für Vielfalt
Bei Sanofi führen unterschiedliche Perspektiven zu den besten Lösungen für Patient*innen. Erfahre von Monique Vessey, unserer Leiterin der Supply Chain -Transformation, wie ihre persönliche Geschichte ihre Arbeit bei der Bereitstellung lebenswichtiger Medikamente prägt.

"Manufacturing & Supply bildet die Brücke zwischen der Wissenschaft in unseren Forschungslaboren und den Menschen und Gemeinschaften, die wir versorgen."

Brendan O’Callaghan
Executive Vice President of Manufacturing and Supply
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