Nuvalent, Inc.
11 - 50 employees
🧬 Biotechnology
💊 Pharmaceuticals
Biotechnology • Pharmaceuticals
Nuvalent, Inc. is a biotechnology company focused on developing targeted therapies for patients with cancer. With a strong foundation in chemistry and structure-based drug discovery, Nuvalent designs innovative small molecules to effectively inhibit kinase targets, overcoming challenges of resistance and selectivity. The company collaborates with physician-scientists to address patient needs and limitations of existing therapies, ensuring their solutions are built for patients and driven by a deep sense of purpose. Nuvalent is committed to using their expertise to deliver precisely targeted cancer treatments.
Manager, Quality Computerized System Validation
🕒 May 18
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Nuvalent, Inc.
11 - 50 employees
🧬 Biotechnology
💊 Pharmaceuticals
Biotechnology • Pharmaceuticals
Nuvalent, Inc. is a biotechnology company focused on developing targeted therapies for patients with cancer. With a strong foundation in chemistry and structure-based drug discovery, Nuvalent designs innovative small molecules to effectively inhibit kinase targets, overcoming challenges of resistance and selectivity. The company collaborates with physician-scientists to address patient needs and limitations of existing therapies, ensuring their solutions are built for patients and driven by a deep sense of purpose. Nuvalent is committed to using their expertise to deliver precisely targeted cancer treatments.
📋 Description
• 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
• 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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