Head of QA Ops APU 11 Forbes
Sanofi
August 25, 2026
On-site
Northborough, MA
$133,500 - $192,833.33 USD yearly
Operations
Main Responsibilities:
- Batch Review & Disposition: Review and prepare batch disposition for all intermediates and finished goods manufactured within the assigned area (final accountability under the QAP, depending on local regulations).
- Regulatory Readiness: Ensure readiness for inspections by national and international agencies by implementing specific requirements for the area.
- Annual Quality Objectives: Develop and implement annual quality assurance operation objectives aligned with organizational strategy.
- Quality Procedures: Develop and implement quality operation procedures supporting proper execution of manufacturing activities.
- Compliance & Risk Management: Maintain systems to identify, track, and mitigate compliance and quality risks.
- Quality Event Closure: Ensure timely closure of deviations, CAPAs, and change controls.
Detailed Responsibilities:
- Oversee the manufacturing process to ensure steps are validated and follow SOPs.
- Establish and monitor quality assurance metrics/KPIs and report performance.
- Promote a quality culture; drive continuous improvement.
- Evaluate/recommend new technologies and tools.
- Lead management reviews and lead/manage the QA Ops team (hiring, training, coaching, development, performance evaluation).
Qualifications:
- Bachelor’s degree in Life Sciences (or related) with 8+ years in quality functions OR Master’s degree with 6+ years.
Preferred Skills/Experience:
- Regulated industry experience (pharma/biotech/biologics/cell & gene therapy).
- Drug product manufacturing experience.
- Strong GMP and quality assurance knowledge; analyze complex data; high accuracy; strong verbal/written communication.
- Inspection management experience; corrective action expertise; manage multiple projects; English proficiency.
Benefits:
- Health and wellbeing benefits, including high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Batch Review & Disposition: Review and prepare batch disposition for all intermediates and finished goods manufactured within the assigned area (final accountability under the QAP, depending on local regulations).
- Regulatory Readiness: Ensure readiness for inspections by national and international agencies by implementing specific requirements for the area.
- Annual Quality Objectives: Develop and implement annual quality assurance operation objectives aligned with organizational strategy.
- Quality Procedures: Develop and implement quality operation procedures supporting proper execution of manufacturing activities.
- Compliance & Risk Management: Maintain systems to identify, track, and mitigate compliance and quality risks.
- Quality Event Closure: Ensure timely closure of deviations, CAPAs, and change controls.
Detailed Responsibilities:
- Oversee the manufacturing process to ensure steps are validated and follow SOPs.
- Establish and monitor quality assurance metrics/KPIs and report performance.
- Promote a quality culture; drive continuous improvement.
- Evaluate/recommend new technologies and tools.
- Lead management reviews and lead/manage the QA Ops team (hiring, training, coaching, development, performance evaluation).
Qualifications:
- Bachelor’s degree in Life Sciences (or related) with 8+ years in quality functions OR Master’s degree with 6+ years.
Preferred Skills/Experience:
- Regulated industry experience (pharma/biotech/biologics/cell & gene therapy).
- Drug product manufacturing experience.
- Strong GMP and quality assurance knowledge; analyze complex data; high accuracy; strong verbal/written communication.
- Inspection management experience; corrective action expertise; manage multiple projects; English proficiency.
Benefits:
- Health and wellbeing benefits, including high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.