Director, Quality Systems
$191,500–$247,500 year
On-siteFramingham, Massachusetts, United States
Job Summary
Oversee a compliant Quality System per ICH Q10, managing document control, training, change control, deviation management, CAPA, and quality metrics. Lead the international quality systems team and maintain electronic documentation systems like MasterControl. Drive continuous improvement initiatives, facilitate cross-functional training, and provide leadership to escalate quality issues to ensure regulatory compliance. Support inspection readiness by mitigating risks and coordinating responses within regulatory timelines. Based in Framingham with a 5-day on-site expectation, this role partners across functions to maintain system health.
Required Qualifications
- 10 years' experience working in a Quality Assurance or Quality Systems role in the pharmaceutical industry
- Experience with electronical documentation systems
- Experience with inspection management
- Bachelor's degree or equivalent
- Continuing education or advanced degree in a biological or pharma industry area
- This position is based in our Framingham location
- typically has a 5-day on-site expectation
Desired Qualifications
- Project Management/Operational Excellence experience with Lean, Six Sigma, or both
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