Manager, Quality Computerized System Validation (CSV)
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 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.
Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.
Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.
Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.
Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “[email protected]” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.
If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.
Nuvalent is focused on developing selective medicines to meet the specific needs of cancer patients. With a team of experienced scientists and industry veterans, the company leverages its deep expertise in chemistry and drug discovery to tackle challenges in oncology drug development.