Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

External Job Description

Job Title: Quality Business Owner

Grade: L3-1

Hiring Manager: Marissa Cooney

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.

Your job, as Quality Business Owner within our Quality Systems Team will be to own process, system and data. Establish and prioritize process evolutions for the site. Support audit and inspection and present the process to auditors and inspectors. Proactively identify remediation actions from findings during internal and external audits, under control of the global process owner.

Identify training needs and ensure the team is informed of inspections and audits outcomes.

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:

• Conducting routine data quality checks and validations to identify and address any process, system or data issue.
• Developing and delivering training programs, principles and best practices.
• Identifying and assessing risks and implementing mitigation strategies.
• Leading continuous improvement initiatives on-site in line with global processes and practices
• Overseeing the computerized systems associated to ensure they meet all requirements
• Establishing and monitoring key performance indicators in line with global guidance
• Being representative of the site in the CoP and if requested participating in the CoE while ensuring local communication. 
• Representing Sanofi global quality when interacting with health authorities for global processes
• Responsible for overseeing overall QMS health at the Mass BioCampus facilities to ensure quality and compliance. 
• Responsible for timely compilation of data for, and compliance to the procedures that govern Quarterly Management Reviews, Product Quality Reviews, Site Quality Council, Site Risk Profile, and investigation system maintenance for site needs.

About You

• Bachelor’s degree in science or a relevant field – required.
• 5+ years of experience in quality or manufacturing with deviations and CAPA management within the pharmaceutical/biotech industry – required.
• Experience with change controls and complaints – preferred. 
• Ability to analyze complex data sets and identify patterns, discrepancies, and areas for improvement (using PowerBI and Excel).
• Experience reviewing and reporting KPIs.
• Experience working with global partners is preferred.
• Strong focus on continuous improvement with the ability to implement plans successfully.
• Strong verbal and written communication skills with the ability to work collaboratively with others.

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.