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

External Job Description

Job Title: QC Key User

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 QC Key User within our Digital Team, will be to be represent the site in the Business Operating Communities (BOC) related to QC digital core models, led by the global, in his/her scope and ensure local communication.

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:

• Executing local deployments of QC digital solutions (core model and local), in accordance with defined deployment plans and validation protocols.
• Issuing all local documentation related to QC digital solutions in scope, required to ensure their usage and maintenance in an appropriate way.
• Providing training and support of end-users on QC digital tools (in coordination with Sanofi global teams for core models).
• Maintaining and updating master data and end-user access to the QC digital tools, according to defined requirements and documentation.
• Informing manager of any event related to digital systems in scope in a timely manner to ensure investigation and impact assessment are performed appropriately.
• Alert and escalate any issue/event that require investigation and escalation.
• Actively participate in any investigation, where involved, to ensure investigations and impact assessment are performed appropriately.
• Build mitigation/remediation plans related to inspection readiness gaps, findings, and deviations.
• Executing assigned CAPAs related to remediation plans, mitigation plans and continuous improvements

About You

Education

• BS – Science or related field of study – required.

Experience

• 8+ years' experience in a quality control, laboratory or manufacturing setting within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements – required.
• 5+ years' experience in validation or LIMS – preferred.

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.

#GD-SG   
#LI-GZ 
#LI-Onsite
#vhd

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.