Quality Manager of CMO

Job Title : Quality Manager of CMO

Location : Northborough, MA or Swiftwater, PA

About the Job

Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster.

As Quality Manager (QA) of CMO within External Manufacturing & Supply (EM&S), you will be responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs), and / or Business Partners (BPs) involved in the manufacture, testing, and transport of Sanofi products.

EM&S QA interacts with functional units within the entire Sanofi organization, both within EM&S and with global to ensure compliance with internal and regulatory requirements for the disposition of intermediates (e.g. API, drug substance), semi- finished products (e.g. naked vials and syringes), and finished products (drug, combination product, or medical devices), meeting the required product / device quality and safety while adhering to the supply needs.

EM&S QA has responsibility for CMO and CLO activities related to vaccines and products treating Rare Diseases and Blood Disorders, Multiple Sclerosis (MS), cancer and diabetes.

EM&S QA has offices based in North America, Europe, and Asia.

About Sanofi :

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

Main Responsibilities :

You will be responsible for managing the required quality activities and documentation associated with a CMO / CLO / BP, ensuring that the CMO / CLO / BP delivers products in compliance with Sanofis requirements and specifications.

This includes the following :

Be the Quality representative engaged in internal core team and joint meetings with the CMO / CLO / BP.

Responsible for the quality oversight of the CMO / CLO / BP cGMP documents and records, including but not limited to : batch production records, validation protocols / reports, change controls, deviations, CAPA, lab investigations, complaint investigations, product quality review, quality agreements. The responsibility includes ensuring applicable documents / records receive the appropriate level of Sanofi SME review and approval in accordance with requirements of Sanofi procedures and standards.

Responsible for product release in accordance with approved specifications and procedures. Support the Qualified Person for lot disposition in Europe.

Monitor the CMO / CLO / BP performance to established key performance indicators (KPI) and report and escalate adverse trends.

Write and negotiate the Quality Agreements with the CMO / CLO / BP by establishing the quality conditions and assessing capacities and risks.

Demonstrate understanding of applicable US, EU, and other applicable local regulations, as well as global regulations related to manufacture of medicinal products.

Provide support to the team for Quality Alert or any other Quality hot topic management related to the CMO / CLO / BP.

Nice to have : Experience with Quality oversight of medical devices

Demonstrate understanding of applicable regulations related to manufacture of medical devices as well as medical device development (design control), risk management process (according to ISO 14971), and related documentation.

Write and review the quality management documentation related to medical devices.

Ensure the involvement of design control and risk management SMEs.

Responsible for medical device release in accordance with approved specifications and procedures.

About You

Experience :

Bachelors degree required.

Minimum 10 years of experience working in cGxP or other regulated environment for biotechnology, aseptic pharmaceutical products or medical devices.

Minimum 5 years of experience in Quality role is a must, working in several regulatory environments (FDA, EMA, WHO, ISO 13485, MDSAP or EU MDR).

Soft and technical skills :

Demonstrated ability to perform work that requires independent decision making and the exercise of independent judgment and discretion.

Excellent communication and negotiation skills.

Function well in highly matrixed organization

Change agent, capable of influencing others and implementing new ways of working

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 its 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.

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