Validation Lifecycle & Periodic Review Program Manager
On-siteThousand Oaks, California, United States
Job Summary
Lead and manage Validation Lifecycle and Periodic Review programs for GMP equipment, facilities, utilities, controlled temperature chambers, and computerized systems. Own client interface, develop execution plans and resource forecasts, and drive timely completion of validation lifecycle deliverables. Provide technical leadership, mentorship to project teams, oversee VMPs and APR activities, coordinate cross-workstream efforts, and ensure compliance with GMP requirements and internal quality standards. Apply experience in risk assessment, project planning, performance metrics, documentation quality, and deployment of validation lifecycle processes (EQPR, CTCPR, CSPR, AATR) with systems such as Maximo, TrackWise, Kneat, CDOCS, and ServiceNow. Strong emphasis on leadership, communication, and program-management skills to deliver validated systems throughout their lifecycle.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Quality, Computer Science, or related technical discipline
- Minimum 8 years of experience in pharmaceutical/biotech/regulated manufacturing environments
- Minimum 3 years of experience leading validation, quality, compliance, engineering, or lifecycle management programs
- Strong knowledge of GMP regulations and validation lifecycle principles
- Experience managing multidisciplinary technical teams
- Excellent written and verbal communication skills
- Strong organizational, planning, and leadership abilities
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