Director of Quality Compliance & Regulatory Excellence

BioSpace; Framingham (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Sanofi Inc. in Framingham, MA is seeking a Head of Quality Compliance to oversee GMP oversight for biologics manufacturing and release activities. The role leads the site Quality Assurance program and ensures readiness for regulatory inspections across Framingham sites and Northborough.

The position requires a strong background in cGMP, 10+ years of experience, and proven leadership in driving a culture of quality and continuous improvement. This is a full-time role based in Framingham, MA.

Qualifications

• Bachelor's degree in science or equivalent with 10+ years of experience in a cGMP regulated industry.
• Master's degree with 8+ years experience in a cGMP regulated industry (human pharmaceutical drug, vaccines, and/or biologics).
• Experience hosting and managing regulatory inspections (PAI, General GMP, For-Cause inspections, etc.).
• Proficient in computer software programs and applications.
• Effective communication skills (listening, verbal and written).
• Ability to collaborate across functions and throughout all levels.

Responsibilities

• Developing, implementing, and maintaining an effective compliance program.
• Ensuring Site compliance with laws, regulations, and standards in the pharmaceutical industry.
• Establishing relationships with regulators, associations, customers, suppliers, and stakeholders.
• Maintaining a system to identify, track, and mitigate quality risks.
• Preparing for regulatory inspections and ensuring readiness.

Skills

Regulatory inspections

Leadership

Cross-functional collaboration

Project management

Effective communication

cGMP/diligence

Education

Bachelor's degree in science or equivalent

Master's degree (preferred)

Job description

Sanofi Inc. in Framingham, MA is seeking a Head of Quality Compliance to oversee GMP oversight for biologics manufacturing and release activities. The role leads the site Quality Assurance program and ensures readiness for regulatory inspections across Framingham sites and Northborough.

The position requires a strong background in cGMP, 10+ years of experience, and proven leadership in driving a culture of quality and continuous improvement. This is a full-time role based in Framingham, MA.