Sanofi Group Quality Operations Specialist - VIE Contract (W/M) in Westborough, Massachusetts

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide.

Therefore, only applications that are submitted in English will be considered.

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.

We are looking for a candidate for a VIE mission of:

Quality Operations Specialist - VIE Contract (W/M)

This role reports to the Senior Director, Quality and Regulatory, EM (External Manufacturing) North America and is part of team that has primary responsibility for providing Quality oversight for 3rd Party Manufacturing (Contract Manufacturing Operations) to oversee activities of Quality Assurance/Quality Control 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.

Responsibilities:

  • Ensuring the Quality and Regulatory Compliance of products sub-contracted to external entities on behalf of Sanofi in accordance with Good Manufacturing Practices and Sanofi Quality directives

  • Ensuring 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

  • Supporting projects as assigned such as new product launch teams

  • Identifying and assising in the resolution of quality related issues that impact Good Manufacturing Practices compliance, regulatory filings, or other risks, to Sanofi products

  • Participating with subcontractors to find solutions concerning quality issues

  • Responding to customer complaints, including close out and determination of corrective actions

  • Reviewing/Approving sub-contractor's validation protocols, Master Documents and significant deviations and investigations

  • 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

  • Assisting in implementation and enhancement of Sanofi IT systems

Requirements:

  • Master Degree of Science

  • Minimum 1 year of experience in Pharmaceutical Operations or Quality Operations with the application of Good Manufacturing Practices in the Pharmaceutical or related regulated industry

  • Proficiency in English

  • Knowledge of French to effectively interface with headquarters

  • Some travel required

  • Excellent oral and written communication skills in Good Manufacturing Practices documentation

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

  • Excellent team work in dealing with internal and external partners with the ability to lead and manage quality related projects

  • 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 Good Manufacturing Practices and regulatory requirements

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

  • Project management skills

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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