Senior Manager, Quality Operations, External Manufacturing

Job Title: Senior Manager, Quality Operations, External Manufacturing

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 device regulation 2017/745, ISO 14971, ISO 10993 series, IEC 62366, ISO 11040 series, ISO 11608 series.

• Sound technical understanding of medical device development (design control) and risk management process (according to ISO 14971) and related documentation.

• Interpersonal skills to interface with suppliers and customer to develop privileged communications and relationship

• Excellent team work and negotiation skills in dealing with internal and external partners with the ability to lead and manage quality related projects. Effectively communicate at all levels of associates in the Sanofi organization (or supplier and customer at all levels

• The incumbent should possess significant technical knowledge related to typical Quality Assurance activities in the medical device industries especially those related to handling product complaints and the associated regulations

• Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, lyophilized and drug/device combination products and medical devices.

• Project management skills

Basic Qualifications

• Bachelor of Science

• Minimum of 5-7 years of experience in Pharmaceutical Operations or Quality Operations, with a strong focus on the application of cGMPs within the pharmaceutical industry.

• Plus, minimum of 3-4 years of experience in Regulatory Affairs or Quality Management Systems within the medical device industry.

• Previous experience working with sterile/implantable medical devices is required.

Preferred Qualifications

• ASQ Certified Quality Engineer certification is a plus.

• Ability to speak French is a plus but is not required.

Travel:

• 25%domestic/internationaltravel.

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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