Manager, Quality Computerized System Validation

Nuvalent, Inc.

Manager of Quality Computerized System Validation responsible for GxP systems in a pharmaceutical company. Collaborating across departments in a remote model to ensure compliance and quality.

Posted 5/18/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSeniorLead💰 $125,000 - $145,000 per yearWebsite

Tech Stack

Tools & technologies

CloudSDLC

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Comp & perks

medical, dental, and vision insurance
401(k) retirement savings plan
generous paid time off (including a summer and winter company shutdown)
comprehensive benefit package

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GxP computerized system validationCSV policiesSOPsrisk-based validationdata integrity principleschange controlsdeviation investigationscloud-based systems validationSaaS systems validationsystem lifecycle management

Soft Skills

collaborationcommunicationproblem-solvingattention to detailanalytical thinkingadaptabilityleadershiporganizational skillsproactive approachaudit readiness