Nuvalent, Inc.
pharmaceutical
Manager,QualityComputerizedSystemValidation(CSV)
Neural analysis suggests this role is
optimal for Mid candidates.
“Manager, Quality Computerized System Validation (CSV) at Nuvalent, Inc.. Skills: GxP computerized system validation, CSV, SDLC, Part 11, Annex 11, ICH E6(R3) Data Governance, data integrity principles, cloud-based systems validation, SaaS systems validation, Veeva QualityDocs. Maintaining the validation lifecycle of GxP-regulated computerized systems across the organization.. Partner with IT, Quality, Regulatory, Clinical, TechOps, Pharmacovigilance, and vendors to support GxP system implementat”
Industry & Context.
Risk-based decision making; Strategic thinking with practical execution
Ability to work Eastern Time Zone and across time zones as needed
What They're Looking For.
Must Have
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., understanding of change management and system lifecycle management.
What You'll Do.
Maintaining the validation lifecycle of GxP-regulated computerized systems across the organization.
and vendors to support GxP system implementations
and continuously improve CSV policies
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
and regulatory inspections.
Review and approve GxP system validation deliverables
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.
How You'll Work.
Team & Collaboration
Partner with IT, Quality, Regulatory, Clinical, TechOps, Pharmacovigilance, and vendors to support GxP system implementations, enhancements, and upgrades.; Act as CSV subject during internal audits, vendor audits, and regulatory inspections.
Communication Scope
excellent cross-functional communication skills; written and verbal communication
Full Job Description
The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 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 ind
Applying for this Manager, Quality Computerized System Validation (CSV) role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Greenhouse
- Create a Greenhouse profile before applying — it saves time across multiple applications.
- Upload your resume as a PDF; the parser handles it better than Word.
- Answer all knockout questions carefully — wrong answers auto-reject before a human sees you.
- Enable email notifications to track application status in real time.
ANONYMOUS · UNFILTERED
What do employees actually say about Nuvalent, Inc.?
Real rants from real employees. Read before you apply.