Senior Quality Specialist General Medicine VIE Contract

Sanofi • Framingham, MA

8d • Onsite

About The Position

As Senior Quality Specialist General Medicine VIE within our Quality System team, you’ll interact extensively with North American manufacturing/packaging sites, contract manufacturers, and with sites inside and outside the US which manufacture products that include all dosage forms for numerous global markets. You will work closely with the contractors, quality team, supply chain, Manufacturing Science and Technology (MSAT), regulatory, and other appropriate groups to ensure compliance and continuous improvement in quality functions to ensure compliance with Current Good Manufacturing Practices (cGMPs) and regulatory submissions. 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.

Requirements

• 1-3 years in Pharmaceutical Operations or Quality Operations with the application of cGMPs in the Pharmaceutical or related regulated industry.
• Experience in third party manufacturing Quality and Regulatory function and/or same plat experience.
• Excellent oral and written communication skills in cGMP documentation
• Interpersonal skills to interface with suppliers and customers to develop privileged communications and relationships.
• Excellent teamwork 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
• 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.
• Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, lyophilized and medical drug/device combinations.
• Project management skills.
• Bachelor’s degree in Science or related field.
• Fluent English (written & verbal).

Responsibilities

• Ensures the Quality and Regulatory compliance of products subcontracted 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 relevant management for complaints, deviations, change controls, non-conformities, or any activity aiming to ensure the production, the control, and the release/disposition of products accordingly with Quality, regulatory, and procedural requirements.
• Strengthens the Quality and Regulatory strategy particularly during crisis management and verify 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 with Sanofi Quality Directives, (cGMPs, and regulatory filings. Leads or participates in the subcontractors’ audits and managers the CAPAs that follow.
• Supports and manage projects assigned such as new product launch, onboarding/offboarding or subcontractors and products.
• Identify and assist in the resolution of quality related issues that impact cGMP compliance, regulatory filing, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior