Senior Manager, Quality Operations, External Manufacturing

Job Title: Senior Manager, Quality Operations, External Manufacturing

Location: Morristown, NJ

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.

This role reports to the Senior Director, Quality and Regulatory, EM-NA and is part of team that has primary responsibility for providing Quality oversight for 3rd Party Manufacturing (Contract Manufacturing Operations) to oversee activities of QA/QC and compliance functions to ensure compliance with current Good Manufacturing Practices (cGMPs). This position interacts extensively with North American manufacturing/packaging sites, contract manufacturers, and with sites outside the U.S. which manufacture products that include all dosage forms including medical devices (including sterile and implantable), combination products, injectables, lyophilized injectables, oral dosage, semi-solids and liquids for numerous global markets. The individual works closely with the Contractor, Quality Control, Planning and other appropriate groups to ensure compliance and continuous improvement in quality functions to ensure compliance with cGMPs, medical device quality management system requirements and regulatory submissions.

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:

• Ensures the Quality and Regulatory Compliance of products sub-contracted to external entities on behalf of Sanofi in accordance with cGMPs, ISO 13485, 21CFR part 820, MDSAP and Sanofi Quality directives.

• Ensures the efficiency of Quality System implemented between Sanofi and the sub- contractors ensuring a relevant management for complaints, deviations, change controls, non-conformities or any activity aiming to ensure the production, the control and the release of products accordingly with Quality requirements.

• Strengthens the Quality and Regulatory strategy particularly during crisis management and verifies the implementation of the relevant action plans.

• Support the External Manufacturing North America Audit Program by working with and conducting contractor audits to assure compliance to Sanofi Quality Directives, current Good Manufacturing Practices (cGMPs), required quality systems and documentation to meet regulatory requirements for medical devices & combination products and regulatory filings. Leads or participates to the subcontractors' audits and manages the CAPAs that follow.

• Support projects as assigned such as new product launch teams. Identify and assist in the resolution of quality related issues that impact cGMP compliance, quality systems compliance to applicable requirements, (such as ISO 13485, 21 CFR part 820, MDSAP), design control and risk management, regulatory filings, or other risks, to Sanofi products. Participates with subcontractors to find solutions concerning quality issues.

• Respond to customer complaints, including close out and determination of corrective actions. Identify and prevent or resolve issues that could impact the continuity of supply of existing products.

• Review/Approve sub-contractor's validation protocols, Master Documents and significant deviations and investigations.

• Regular and frequent contact with vendors through formal meeting (systematic business review meeting) or informally when issues can't wait. Constant contact with the Senior Director of Quality, EM- North America and Global Quality.

• Regular contact with Legal to ensure the compliance of the activity to all laws and in preparation of Quality Agreements.

• Regular contact with medical devices technical and quality experts.

• Collaborate with numerous country's Sanofi affiliates.

About You

Knowledge/Competencies

• Excellent oral and written communication skills in cGMP documentation.

• Experience in 3rd party manufacturing Quality and Regulatory function and/or same plant experience

• Understanding of regulations and standards affecting combination products and medical devices required, which include notably ISO 13485, 21CFR part 820, MDSAP, EU Medical