Quality Manager - External Manufacturing And Supply Large Molecules Specialty Care

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 Manager - External Manufacturing and Supply Large Molecules Specialty Care within our External Manufacturing and Supply (EM&S) Large Molecule Specialty Care organization, will be to be the Quality point of contact for the CMO, providing direct support from a quality and compliance perspective. The Quality manager coordinates oversight of all quality interactions with the CMO and serves as the quality representative in both internal core team meetings and joint meetings with the CMO. The role is responsible to ensure cGMP documents and records obtain and meet expectations for the required Sanofi review and approval in accordance with Sanofi procedures and guidelines.

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:

• Act as CMO Quality site contact, responsible for CMO quality oversight; engage in internal core team meetings and joint meetings with the CMO.

• Responsible for quality oversight of cGMP documents and records (includes but not limited to: batch production records, validation protocols/reports, product release documentation, change controls, deviations, CAPA, lab investigations, complaint investigations, product quality review, quality agreements):

• Responsibility includes ensuring applicable documents/records receive the appropriate level of Sanofi SME review in accordance with requirements of Sanofi procedures and standards.

• Responsible to review and approve documents in the QA capacity.

• Responsible for product QA release in accordance with approved specifications and procedures

• Monitor contractor performance to established key performance indicators (KPI) and report and escalate adverse trends.

• Demonstrate understanding of applicable health authority regulations related to manufacture of medicinal products (small molecules and biologics).

About you

• Bachelor's degree and strong experience working in a cGxP or other regulated environment, plus solid experience in a Quality role.

• Prio experience in a supervisory and/or management role.

• Familiarity with global cGMP and ISO regulations relating to medicinal products is helpful.

• Experience with data analysis, trending, and presenting material within multi-functional environment a plus.

• Ability to travel up to 15% - primarily domestic - is required.

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!