Quality Compliance Leader — Regulatory Inspections

Sanofi; Framingham (MA); On-site; USD 139,750 - 232,916; Full time

Job summary

Sanofi Framingham is seeking a Head of Quality Compliance to lead the site-wide quality program and ensure regulatory compliance across biologics operations. You will drive readiness for inspections, manage risk, and coordinate with regulators and internal teams.

The role requires extensive cGMP experience, leadership in a regulated environment, and a track record of delivering compliance improvements and audits.

Qualifications

• Bachelor’s or Master’s degree in a science field with 10+ years (Bachelor) or 8+ years (Master) in a cGMP setting.
• Experience hosting/regulatory inspections (PAI, GMP, For-Cause) is required.
• Proven leadership of compliance teams and cross-functional projects.

Responsibilities

• Develop, implement, and maintain an effective site quality compliance program.
• Ensure compliance with applicable laws, regulations, and industry standards.
• Manage regulatory inspections and prepare for inspections across sites.
• Identify, track, and mitigate quality and compliance risks with KPIs and metrics.
• Lead and develop the compliance team and communicate with stakeholders.

Skills

cGMP experience (Regulatory)

Regulatory inspections

Leadership

Cross-functional collaboration

Quality management

Education

Bachelor’s degree in science

Master’s degree in science

Job description

Sanofi Framingham is seeking a Head of Quality Compliance to lead the site-wide quality program and ensure regulatory compliance across biologics operations. You will drive readiness for inspections, manage risk, and coordinate with regulators and internal teams.

The role requires extensive cGMP experience, leadership in a regulated environment, and a track record of delivering compliance improvements and audits.