Quality Third Party Management Specialist

Sanofi • Framingham, MA

20h • $69,000 - $99,667 • Onsite

About The Position

The Third-Party Quality team delivers strategic leadership and comprehensive oversight for Third Party Quality compliance across the MA Bio Campus. Our focus is on ensuring excellence in quality standardsand regulatory adherence in all external partnerships. The Third-Party Management Specialist is responsible for overseeing Third Party Quality for the MA BioCampus. This role is crucial in maintaining high-quality standards and ensuring compliance in our Relationships with external partners. 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.

Requirements

• Bachelor’s degree in Life Sciences (Biology, Chemistry, Microbiology) , Engineering (Chemical, Biomedical, Industrial Pharmaceutical Sciences or related field, or equivalent 5+ work experience in Supplier Quality.
• 3+ years Quality and/or Operations experience in a biotech/pharmaceutical cGMP Manufacturing Environment within a FDA regulated industry.
• Strong analytical skills, excellent communication abilities, and a thorough understanding of quality management systems in the pharmaceutical industry.

Nice To Haves

• Proficient in Veeva quality management system
• Experienced in third-party quality investigations, quality agreements, and supplier change notifications
• Skilled in analyzing complex documentation for regulatory compliance
• Strong knowledge of global pharmaceutical regulations (US, EU, Canada, Japan, Australia)
• Excellent communication and presentation skills, with ability to influence senior management
• Experienced in LEAN manufacturing principles and continuous improvement methodologies
• Adept at identifying trends and developing key performance metrics

Responsibilities

• Lead the SCN process
• Provide training on SCN workflow
• Ensure cross-functional approach to SCN completion
• Coordinate subject matter expert involvement
• Maintain system health and timely responses
• Collaborate with Third Parties on investigations
• Ensure cross-functional approach to TPE completion
• Manage returns of investigation materials to third parties
• Support Sanofi MA sites and Global quality agreements
• Develop and maintain periodic review schedules
• Assign and oversee quality agreement reviews
• Ensure all quality agreements are approved and properly documented
• Interpret complex documentation for new and current compliance procedures
• Stay informed on regulatory enforcement trends and actions
• Assist in resolving compliance issues related to third parties
• Work closely and collaborating with Manufacturing, Continuous Improvement, Operational Excellence, Quality Assurance, Quality Control, Facilities, and other departments

Benefits

• Endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• A thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• High-quality healthcare, prevention and wellness programs.
• At least 14 weeks’ gender-neutral parental leave.
• Employees may be eligible to participate in Company employee benefit programs.

What This Job Offers

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