Sanofi Group Manager, Quality Operations, External Manufacturing-NA, Westborough, MA in Westborough, Massachusetts

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, 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 and regulatory submissions.

PRINCIPAL ACCOUNTABILITIES

  • Ensures the Quality and Regulatory Compliance of products sub-contracted to external entities on behalf of Sanofi in accordance with cGMPs 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), 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, regulatory filings, or other risks, to Sanofi products.

  • Develops and negotiates the subcontractors Quality Agreements defining the responsibilities between both parties and provides quality advice to subcontractors.

  • 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 and Regulatory, 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.

  • Collaborate with numerous country's affiliates' Heads of Quality.

  • Collaborate with other company divisions to support Worldwide Outsourcing and synergies such as Pasteur, Chattem, Genzyme and Merial.

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

  • 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 (from operator to vice president) or supplier and customer at all levels (including CEO)

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

  • Thorough knowledge of GMP's and regulatory requirements (including Sarbanes Oxley)

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

  • Project management skills

Type and Length of Experience:

  • Bachelor of Science

  • 5-7 years in Pharmaceutical Operations or Quality Operations with the application of cGMPs in thePharmaceutical or related regulated industry

Desirable But Not Essential:

  • Knowledge of French to effectively interface with headquarters

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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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life