Associate Director, Computer Systems Assurance (Quality)
Core
Own and advance the Computer Systems Assurance (CSA) program for GxP-regulated SaaS and cloud-hosted platforms in a clinical-stage biopharmaceutical company.
Role type
Associate Director, Computer Systems Assurance (Quality)
Builds
Validated GxP systems (eQMS, clinical data management, regulatory info management) for drug discovery and development
Domain
Biopharmaceutical / GxP Regulatory Compliance
Required skills
GxP computer systems validation, SaaS/cloud platform qualification, FDA 21 CFR Part 11, EU Annex 11, GAMP 5, risk-based validation strategy, vendor assessment (SOC 2), data integrity (ALCOA+), change control management, validation documentation (VMP, URS, IQ/OQ/PQ)
Preferred skills
None stated
Technologies
Veeva Vault, SaaS platforms, cloud-hosted platforms
Responsibilities
Own and maintain CSA policy framework and risk-based validation strategy; Lead validation activities for GxP SaaS platforms; Serve as SME for 21 CFR Part 11 and data integrity; Manage change control and periodic review programs; Support regulatory inspections and submissions; Provide CSA training to stakeholders
Seniority
Senior, hands-on IC with program ownership