Quality Manager External Manufacturing North America - VIE Contract

Quality Manager External Manufacturing North America - VIE Contract

• Location: United States of America, Framingham
• Target start date: 01/04/2025

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. Please make sure to apply with your personal email address.

About the job

Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As Quality Manager External Manufacturing North America VIE in our Quality Assurance team you will interacts extensively with North American manufacturing/packaging sites, contract manufacturers, and with sites outside the Unites States 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. You will work closely with the Contractor, Quality Control, Planning 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.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main responsibilities:

• Ensures the Quality and Regulatory Compliance of products sub-contracted to external entities on behalf of Sanofi in accordance with cGMPs and Sanofi Quality management system.
• 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.
• Support projects as assigned such as new product launch teams and alignment with Sanofi global documents.
• Identify and assist in the resolution of quality related issues that impact cGMP compliance, 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.
• Review/Approve sub-contractor's validation protocols, Master Documents and significant deviations and investigations.
• Assist in developing and negotiating the subcontractors Quality Agreements defining the responsibilities between both parties and providing quality advice to subcontractors.
• Identify and prevent or resolve issues that could impact the continuity of supply of existing products. Regular contact with Legal to ensure the compliance of the activity to all laws and in preparation of Quality Agreements.
• Assist in implementation and enhancement of Sanofi IT systems. Ensure alignment and compliance with Sanofi Global Documents.
• Decision making for quality and compliance issues including but not limited to the disposition of changes, deviations, qualifications/validation, approval of investigations, solve problems by working with quality and technical counterparts at external manufacturing sites as well as the technical/analytical team internally.

About you

Experience:

• 1-2 years of experience in Pharmaceutical Operations or Quality Operations with the application of Good Manufacturing Practices in the Pharmaceutical or related regulated industry.
• Quality assurance experience is a plus.
  

Soft and Technical skills:

• Thorough knowledge of GMP's and regulatory requirements.
• Excellent oral and written communication skills in cGMP documentation.
• Interpersonal skills to interface with suppliers and customer to develop privileged communications and relationship.
• Excellent teamwork in dealing with internal and external partners with the ability to lead and manage quality related projects.
• 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.
• Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, lyophilized and medical drug/device combinations.
• Good Project management skills.
• Proficiency in PowerPoint, Excel.
  

Education:

• Master’s degree within the Pharmaceutical industry / Pharmaceutical Manufacturing / Research & Development or related area.
  

Languages:

• Proficiency in English both written and verbal.