Head of Quality Compliance
Sanofi
August 09, 2026
On-site
Framingham, MA
$161,250 - $232,916.66 USD yearly
Operations
Main Responsibilities:
- Develop, implement, and maintain an effective compliance program.
- Ensure the site complies with applicable pharmaceutical laws, regulations, and standards.
- Build and maintain relationships with regulators and stakeholders; represent the company in compliance matters.
- Identify, track, and mitigate compliance and quality risks.
- Ensure readiness for regulatory inspections related to dossier compliance.
- Report compliance issues to relevant authorities in a timely manner; manage and resolve issues/allegations and drive CAPA.
- Establish and monitor site compliance KPIs/metrics and report results to management.
- Host Business Owners self-inspections and other key compliance systems.
- Drive continuous improvement initiatives and foster a culture of compliance.
- Lead and manage the compliance team (hiring, training, coaching, development, performance evaluation).
Basic Qualifications:
- BS in science (10+ years) or MS (8+ years) in a cGMP-regulated industry (pharmaceutical drugs, vaccines, and/or biologics).
- 8+ years managing people/projects or influencing others.
- Experience hosting/managing regulatory inspections (PAI/GMP/For-Cause, etc.).
- Strong knowledge of cGMP/pharmaceutical regulatory requirements (e.g., 21 CFR Part 11, 210/211, 600/610; EU-GMP/Annex; ISO; ICH; PIC/s) and systems-based inspection approach.
- Experience with aseptic processing, SUT, and digital systems in manufacturing.
- Ability to gown and enter controlled, classified areas.
- Proficiency in computer software; strong verbal/written communication; cross-functional collaboration; proven results and problem-solving.
Benefits (explicit):
- Healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave; rewards package recognizing contribution.
- Develop, implement, and maintain an effective compliance program.
- Ensure the site complies with applicable pharmaceutical laws, regulations, and standards.
- Build and maintain relationships with regulators and stakeholders; represent the company in compliance matters.
- Identify, track, and mitigate compliance and quality risks.
- Ensure readiness for regulatory inspections related to dossier compliance.
- Report compliance issues to relevant authorities in a timely manner; manage and resolve issues/allegations and drive CAPA.
- Establish and monitor site compliance KPIs/metrics and report results to management.
- Host Business Owners self-inspections and other key compliance systems.
- Drive continuous improvement initiatives and foster a culture of compliance.
- Lead and manage the compliance team (hiring, training, coaching, development, performance evaluation).
Basic Qualifications:
- BS in science (10+ years) or MS (8+ years) in a cGMP-regulated industry (pharmaceutical drugs, vaccines, and/or biologics).
- 8+ years managing people/projects or influencing others.
- Experience hosting/managing regulatory inspections (PAI/GMP/For-Cause, etc.).
- Strong knowledge of cGMP/pharmaceutical regulatory requirements (e.g., 21 CFR Part 11, 210/211, 600/610; EU-GMP/Annex; ISO; ICH; PIC/s) and systems-based inspection approach.
- Experience with aseptic processing, SUT, and digital systems in manufacturing.
- Ability to gown and enter controlled, classified areas.
- Proficiency in computer software; strong verbal/written communication; cross-functional collaboration; proven results and problem-solving.
Benefits (explicit):
- Healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave; rewards package recognizing contribution.