Sr. Director, eCompliance – Global Quality Technical Operations
Core
Define and maintain Global Computerized System Validation (CSV) Master Plans, establish standardized Software Development Life Cycles (SDLC) for GxP systems, and govern data integrity and AI compliance across biopharma operations.
Role type
Sr. Director, eCompliance – Global Quality Technical Operations
Builds
Validated cloud/IT infrastructure, enterprise QMS implementations (MasterControl), and AI governance frameworks for batch release.
Domain
Biopharma / GxP Regulatory Compliance / IT Quality Assurance
Deliverable
production ML models | infrastructure | dashboards & analysis
Required skills
GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, GDPR, ALCOA+ principles, Computer Software Assurance (CSA), risk-based testing, change management, regulatory inspection defense
Preferred skills
Master's degree in related field, independent problem solving, cross-functional stakeholder influence
Technologies
MasterControl QMS, eBatch Record, Ignition MES, LIMS, PLC/SCADA, Data Lakehouse
Responsibilities
Define CSV Master Plan transitioning to CSA models; Establish SDLC requirements for GxP systems; Oversee cloud platform qualification and vendor audits; Enforce ALCOA+ data integrity principles; Develop audit trail review protocols; Lead data mapping and risk assessment for global sites; Provide technical oversight for MasterControl rollout; Establish compliance frameworks for AI-assisted batch release; Validate OT integration with engineering systems; Lead organizational change for Compliance by Design; Act as primary Quality liaison to Global IT; Support site teams during complex deployments; Serve as SME for regulatory inspections; Develop and monitor KPIs for system health and compliance.
Seniority
Senior, hands-on IC with supervisory responsibilities (1-10 employees)