Head of QA Ops, APU 11 Forbes
Sanofi
July 01, 2026
On-site
Northborough, MA
$133,500 - $192,833.33 USD yearly
Operations
Main Responsibilities
- Batch Review & Disposition: Review and prepare batch disposition for intermediates and finished goods in the assigned area (final accountability under QAP, per local regulations).
- Regulatory Readiness: Ensure inspection readiness for relevant national/international agencies by implementing applicable requirements.
- Annual Quality Objectives: Develop and implement annual quality assurance operation objectives aligned to organizational strategy.
- Quality Procedures: Develop and implement quality operation procedures supporting proper manufacturing execution.
- 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
- Manufacturing Process Oversight: Oversee manufacturing steps to ensure validation and adherence to SOPs.
- Metrics & Monitoring: Establish metrics, monitor data, and implement action plans.
- KPI Management & Reporting: Track KPIs and report regularly on performance/effectiveness.
- Quality Culture Promotion; Continuous Improvement; Innovation & Technology recommendations.
- Management Reviews: Lead reviews and implement adjustments.
- Team Leadership: Hire, train, coach, develop, and evaluate the QA Operations team.
Qualifications / Requirements
- Bachelor’s Degree in Life Sciences (or related) + 10+ years in pharmaceutical QA.
- Strong GMP and quality assurance knowledge.
- Drug Product Manufacturing experience.
- Analyze complex data; strong accuracy and attention to detail.
- Strong verbal/written communication with team members and regulators.
Expected Technical Skills
- Inspection management experience at a drug product manufacturing site.
- Identify problems and implement effective corrective actions.
- Manage multiple projects; timely completion and quality adherence.
- English proficiency required.
Benefits (if included)
- Health and wellbeing benefits, high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.
- Batch Review & Disposition: Review and prepare batch disposition for intermediates and finished goods in the assigned area (final accountability under QAP, per local regulations).
- Regulatory Readiness: Ensure inspection readiness for relevant national/international agencies by implementing applicable requirements.
- Annual Quality Objectives: Develop and implement annual quality assurance operation objectives aligned to organizational strategy.
- Quality Procedures: Develop and implement quality operation procedures supporting proper manufacturing execution.
- 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
- Manufacturing Process Oversight: Oversee manufacturing steps to ensure validation and adherence to SOPs.
- Metrics & Monitoring: Establish metrics, monitor data, and implement action plans.
- KPI Management & Reporting: Track KPIs and report regularly on performance/effectiveness.
- Quality Culture Promotion; Continuous Improvement; Innovation & Technology recommendations.
- Management Reviews: Lead reviews and implement adjustments.
- Team Leadership: Hire, train, coach, develop, and evaluate the QA Operations team.
Qualifications / Requirements
- Bachelor’s Degree in Life Sciences (or related) + 10+ years in pharmaceutical QA.
- Strong GMP and quality assurance knowledge.
- Drug Product Manufacturing experience.
- Analyze complex data; strong accuracy and attention to detail.
- Strong verbal/written communication with team members and regulators.
Expected Technical Skills
- Inspection management experience at a drug product manufacturing site.
- Identify problems and implement effective corrective actions.
- Manage multiple projects; timely completion and quality adherence.
- English proficiency required.
Benefits (if included)
- Health and wellbeing benefits, high-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.