Job Title: QA Principal Team Lead, Operations

Location: Framingham, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Join our Quality Assurance (QA) Operations team at Sanofi's Framingham Biologics facilities! We ensure cGMP compliance during manufacturing to guarantee the safety, quality, and efficacy of our products.

As the QA Principal Team Lead, you'll provide quality support and direction to Manufacturing, Quality Control, and support functions. In the manager's absence you will lead the QA team, assign tasks, track lot releases, and ensure compliance with cGMPs.

• Leadership: Assign tasks, track lot releases, and delegate activities to Compliance Specialists.
  
• Collaboration: Work closely with manufacturing, facilities, engineering, and Quality Control departments. Function as SME on challenges related to production requiring quality input.
  
• Compliance: Conduct audits, review batch records, approve Change Controls, and support internal audits perform release of intermediates and drug substance for further processing
  
• GEMBA Support: Provide on-the-floor support, issue action notices, and participate in Material Review Board meetings.
  
• Audits: Represent QA during internal and external audits, addressing questions related to QA systems and product disposition.
  
• Deviation Management: Approve deviation investigations, support Deviation Governance meetings, and ensure consistency in Quality Systems.
  
• Decision Making: Challenges include responsible for high complexity decision making related to Quality or Compliance and ensuring that risks or deviation from decisions made by the Quality representative are escalated to QA Operations Management, QA Director or the Quality Site Head as needed to ensure Safety, Identity, Strength, Purity, Quality (SISPQ) of product.
  

• Masters with 7+ years, Bachelor's with 9+ years, Associate's with 11+ years, or High School Diploma with 13+ years in Quality/cGMP. Experience in Quality Engineering/Assurance/Control and knowledge of cGXP regulations and biologics or similar manufacturing processes.
  

• Self-motivated, organized, excellent communicator, detail-oriented, strong interpersonal and project management skills, and proficient in electronic document systems such as Trackwise and/or Veeva, Excel, Word, PowerPoint, and databases.
  

• Ability to gown and enter clean rooms is a requirement for this role.
  

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.