Manager, Quality Computerized System Validation (CSV)

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.

Qualifications
- Bachelor’s degree or related experience.
- 3–5 years’ experience in GxP computerized system validation within pharmaceutical, biotech, or medical device.
- 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.

Competencies
- Risk-based decision making; strategic thinking with practical execution.
- Strong written and verbal communication.
- Attention to detail with business mindset.