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, you’ll 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:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s 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 people’s 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 Sanofi’s 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.