Head of Quality Compliance
Sanofi
August 31, 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 laws, regulations, and industry standards.
- Build and maintain relationships with regulators and other stakeholders; represent the company in compliance matters.
- Maintain a system to identify, track, and mitigate compliance and quality risks.
- Ensure readiness for regulatory inspections related to dossier compliance.
- Report compliance issues to the relevant authorities in a timely manner.
- Manage and resolve compliance issues/allegations and execute appropriate CAPA.
- Establish and monitor site compliance KPIs/metrics and report results to management.
- Host business owners’ self-inspections and other key quality compliance systems.
- Identify and drive continuous improvement to enhance compliance and foster a compliance culture.
- Lead and manage the compliance team (hiring, training, coaching, development, performance evaluation).
Qualifications:
- BS in science or equivalent + 10+ years experience, or MS + 8+ years in a cGMP regulated industry (human pharma drugs, vaccines, and/or biologics).
- 8+ years managing people/projects or influencing others.
- Experience hosting/managing regulatory inspections (e.g., PAI, General GMP, For-Cause).
- Proficient with computer software; strong verbal and written communication.
- Cross-functional collaboration ability.
- Strong working knowledge of cGMP and pharmaceutical regulations (e.g., 21 CFR 11, 210/211, 600/610; EU-GMP/Annex; ISO; ICH; PIC/s).
- In-depth systems-based inspection approach knowledge.
- Understanding of aseptic processing; SUT and digital systems in manufacturing operations.
- Ability to gown and enter controlled, classified areas.
- Project management skills; proven delivery track record.
- Equipment and process validation experience in cGMP environment.
- Knowledge of TQM, ISO, Six Sigma.
- In-depth understanding of FDA/EMA/ICH requirements.
- Proven internal audit management and external inspection preparation/execution/follow-up.
- Ability to analyze complex compliance issues, identify root causes, and develop solutions.
- Proficiency managing multiple compliance projects; strong attention to detail for documentation, audits, and reports.
- Develop, implement, and maintain an effective compliance program.
- Ensure the site complies with applicable laws, regulations, and industry standards.
- Build and maintain relationships with regulators and other stakeholders; represent the company in compliance matters.
- Maintain a system to identify, track, and mitigate compliance and quality risks.
- Ensure readiness for regulatory inspections related to dossier compliance.
- Report compliance issues to the relevant authorities in a timely manner.
- Manage and resolve compliance issues/allegations and execute appropriate CAPA.
- Establish and monitor site compliance KPIs/metrics and report results to management.
- Host business owners’ self-inspections and other key quality compliance systems.
- Identify and drive continuous improvement to enhance compliance and foster a compliance culture.
- Lead and manage the compliance team (hiring, training, coaching, development, performance evaluation).
Qualifications:
- BS in science or equivalent + 10+ years experience, or MS + 8+ years in a cGMP regulated industry (human pharma drugs, vaccines, and/or biologics).
- 8+ years managing people/projects or influencing others.
- Experience hosting/managing regulatory inspections (e.g., PAI, General GMP, For-Cause).
- Proficient with computer software; strong verbal and written communication.
- Cross-functional collaboration ability.
- Strong working knowledge of cGMP and pharmaceutical regulations (e.g., 21 CFR 11, 210/211, 600/610; EU-GMP/Annex; ISO; ICH; PIC/s).
- In-depth systems-based inspection approach knowledge.
- Understanding of aseptic processing; SUT and digital systems in manufacturing operations.
- Ability to gown and enter controlled, classified areas.
- Project management skills; proven delivery track record.
- Equipment and process validation experience in cGMP environment.
- Knowledge of TQM, ISO, Six Sigma.
- In-depth understanding of FDA/EMA/ICH requirements.
- Proven internal audit management and external inspection preparation/execution/follow-up.
- Ability to analyze complex compliance issues, identify root causes, and develop solutions.
- Proficiency managing multiple compliance projects; strong attention to detail for documentation, audits, and reports.