Manager, Quality Computerized System Validation (CSV)

The Role:

Reporting to the Director, Quality Systems, the Manager, Quality Computerized System Validation (CSV) is responsible for maintaining the validation lifecycle of GxP-regulated computerized systems across the organization in a remote pharmaceutical operating model. The ideal candidate is a strategic thinker with strong hands-on validation experience, excellent cross-functional communication skills, and understanding of compliance in a cloud-based and SaaS environment.

Responsibilities:

• 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.

Competencies:

• Risk-based decision making
• Strategic thinking with practical execution
• Strong written and verbal communication
• Attention to detail with business mindset

Qualifications:

• Bachelor’s degree or related experience
• 3-5 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

Additional Information:

Nuvalent is committed to fair and equitable compensation practices, aiming to provide employees with competitive total rewards packages. The targeted salary range reflects what Nuvalent reasonably and in good faith expects to offer for this position at the time of posting, but the final salary determination may be within or outside this range based on various factors, including, but not limited to, experience, skills, education, and market factors. The range will be reviewed regularly and is subject to change. Nuvalent also offers a comprehensive benefit package to support our employees at each stage of their career, financial, health, and well-being journey, including medical, dental, and vision insurance, 401(k) retirement savings plan, generous paid time off (including a summer and winter company shutdown), and much more.