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Manager, Quality Computerized System Validation
Location
Massachusetts
Posted
17 days ago
Salary
$125K - $145K / year
Seniority
Lead
Job Description
Manager, Quality Computerized System Validation
Nuvalent, Inc.
• Partner with IT, Quality, Regulatory, Clinical, TechOps, Pharmacovigilance, and vendors to support GxP system implementations, enhancements, and upgrades. • Develop, maintain, and continuously improve CSV policies, SOPs, and forms aligned with regulatory expectations and industry best practices. • Ensure application of risk-based validation approaches and data integrity principles (ALCOA++). • Act as CSV subject during internal audits, vendor audits, and regulatory inspections. • Review and approve GxP system validation deliverables, change controls, deviation investigations, and periodic reviews. • Assess inspection trends and proactively update validation practices accordingly. • Evaluate vendor documentation for GxP system validation and SDLC for suitability and leverage where appropriate.
Job Requirements
- Bachelor’s degree or related experience
- 8+ years’ experience in GxP computerized system validation within the pharmaceutical, biotech, or medical device industry.
- Veeva QualityDocs experience required.
- Deep knowledge of CSV, SDLC, Part 11, Annex 11, ICH E6(R3) Data Governance, and data integrity principles.
- Experience validating cloud-based and SaaS systems.
- Strong understanding of change management and system lifecycle management.
- Ability to work Eastern Time Zone and across time zones as needed
Benefits
- medical, dental, and vision insurance
- 401(k) retirement savings plan
- generous paid time off (including a summer and winter company shutdown)
- comprehensive benefit package
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