Senior Quality Specialist, General Medicine (VIE)

BioSpace; Framingham (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Sanofi is seeking a Senior Quality Specialist General Medicine for the VIE program in Framingham, MA. You will ensure cGMP compliance for subcontracted products and collaborate with NA manufacturing, contract manufacturers, and global sites.

The role emphasizes quality systems, regulatory submissions, and cross-functional teamwork with MSAT, regulatory, and supply chain to maintain product quality and continuous improvement.

Qualifications

• 1–3 years in Pharmaceutical Operations or Quality Operations applying cGMP.
• Experience with third-party manufacturing Quality and Regulatory function.

Responsibilities

• Ensures Quality and Regulatory compliance of subcontracted products per cGMPs and Sanofi directives.
• Manages quality system activities with contractors including complaints, deviations, change controls, non-conformities, and release/disposition.
• Strengthens Quality and Regulatory strategy during crises and tracks action plan implementation.
• Supports NA External Manufacturing Audit program; conducts contractor audits and manages CAPAs.
• Projects include new product launches, onboarding/offboarding of subcontractors and products.
• Identifies and resolves quality issues impacting cGMP compliance and regulatory filings.
• Develops and negotiates subcontractor Quality Agreements and provides quality guidance to subcontractors.

Skills

cGMP knowledge

Quality Assurance

Regulatory liaison

Audit coordination

Contract manufacturing

Project management

Communication skills

Education

Bachelor's degree in Science or related field

Job description

Sanofi is seeking a Senior Quality Specialist General Medicine for the VIE program in Framingham, MA. You will ensure cGMP compliance for subcontracted products and collaborate with NA manufacturing, contract manufacturers, and global sites.

The role emphasizes quality systems, regulatory submissions, and cross-functional teamwork with MSAT, regulatory, and supply chain to maintain product quality and continuous improvement.