Senior Quality Lead – External Manufacturing NA

Sanofi; Framingham (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Sanofi in Framingham, MA, seeks a Senior Manager Quality, EM&S Gen Med NA, to lead QA/QC oversight of third-party manufacturers, labs, and suppliers. This role partners with cross-functional teams to uphold cGMP compliance and maintain robust QMS processes across NA sites and external partners.

The position requires a science degree and 3+ years in pharmaceutical operations or quality, with travel 25–30% and strong communication for regulatory interactions. Hybrid collaboration is expected.

Qualifications

• Bachelor's degree in a Science field.
• 3+ years of experience in Pharmaceutical Operations or Quality Operations with cGMPs.
• Open to domestic and international travel (25-30% of time).
• Co-op or internship experience will be considered.

Responsibilities

• Ensures QA/QC and regulatory compliance of subcontractors per cGMPs and Sanofi directives.
• Manages quality system activities with sub-contractors, including complaints, deviations, change controls, non-conformities, and release/disposition.
• Leads or participates in audits of subcontractors and manages CAPAs.
• Develops subcontractor Quality Agreements and provides quality guidance.

Skills

Quality oversight

cGMP compliance

Project management

Interpersonal skills

Regulatory interface

Education

Bachelor's degree in a Science field

Tools

Audit programs

Quality agreements

Job description

Sanofi in Framingham, MA, seeks a Senior Manager Quality, EM&S Gen Med NA, to lead QA/QC oversight of third-party manufacturers, labs, and suppliers. This role partners with cross-functional teams to uphold cGMP compliance and maintain robust QMS processes across NA sites and external partners.

The position requires a science degree and 3+ years in pharmaceutical operations or quality, with travel 25–30% and strong communication for regulatory interactions. Hybrid collaboration is expected.