Senior Specialist, Quality Operations - Vaccine

Job Title: Senior Specialist, Quality Operations - Vaccine

Hiring Manager: Christopher Farrell

About the Job

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.

Our Team/ Overview

The mRNA Center of Excellence is an early clinical phase R&D facility within Sanofi vaccines.  The team consists of approximately 20 FTE’s and 6 consultants, supporting the manufacturing of Drug Substance and bulk Drug Product within our Internal Manufacturing team and external CMOs which we partner with.  In house GMP operations consist of the Internal Manufacturing and Quality Control teams.

Main Responsibilities:

• The Senior Specialist of Quality Operations is responsible for ensuring our Quality organization meets all compliance requirements pertaining to Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), FDA, ICH and EMA regulations.

•  The Senior Specialist of Quality Operations will be responsible for helping develop policies and programs in the support of Sanofi Waltham’s mRNA Center of Excellence, inclusive of review and release of manufacturing/test documentation from process development, manufacturing, non-clinical and clinical processes and supply chains. This includes batch records, deviations, CAPAs, CoAs, CoCs, etc.

• This individual will also help with oversite of contract organizations such as CMOs, CROs and CTLs by providing senior level support to project teams leading those efforts. This position will have a special focus on supporting the Quality Control lab. This position is based in the Waltham, MA offices. The ideal candidate will live within a reasonable commuting distance, or be willing to relocate at their own expense.

Key Roles:

Quality Oversight & Compliance

• Serve as Quality point of contact across multiple areas including Internal Manufacturing, Quality Control lab, External Testing Laboratories and CMO project teams

• Provide Quality oversight and guidance to resolve compliance issues related to raw materials, drug substance, bulk drug product, drug product and clinical materials

• Identify, track and escalate potential quality risks

• Support on-the-floor QA activities during manufacturing operations as needed

• Ensure all requirements stipulated in Quality Technical Agreements are met

• Collaborate with Analytical Sciences to develop and improve analytical methods for critical quality attributes when appropriate ·

• Provide expertise on materials to improve performance processes and develop optimized approaches for the technical aspect of material changes.

Documentation & Review

• Review and approve manufacturing documentation including Master Manufacturing Records, Stability Protocols/Reports, Sampling plans and executed Manufacturing Records.

• Review and approve QC/Analytical documents such as Test Methods, Method Transfer Plans and Assessments

• Issue, review, and manage quality events including Deviations, CAPAs, OOS and Lab Investigations

• Write, revise and perform QA review/approval on SOPs, forms, work instructions and other document types

• Provide iShift (SAP) support for GMID and BOM approval

• Collaborate with Quality Control laboratory on the implementation of data integrity controls and QA review of analytical results and laboratory investigations

• Support method lifecycle management by participating in analytical method risk assessments, review/approve method changes and monitor method performance trends

Quality Systems & Continuous Improvement

• Participate in Quality Risk Assessments

• Track and provide quality metrics in support of Quality Council, KPIs and other reportable forums

• Assist with internal and external audits