CSV Associate Director, US East Coast
Core
Provide strategic, technical, and people leadership for Computerized Systems Validation (CSV) across a growing portfolio of projects and operations in the US East Coast.
Role type
Associate Director, CSV
Builds
Compliant validation outcomes for capital projects and system lifecycle activities in regulated GMP environments.
Domain
Life Sciences / Manufacturing / Quality Assurance
Required skills
CSV lifecycle management, risk-based validation methodologies, GMP compliance, stakeholder management, team leadership, audit readiness, technical governance
Preferred skills
Master's degree, ISPE/GAMP certification, Certified Automation Professional, ASQ certification, AI/Machine Learning experience
Technologies
PLC, DCS, SCADA, MES, laboratory systems, analytical systems, digital platforms
Responsibilities
Lead CSV delivery from design through qualification and operational readiness; Provide technical leadership for computerized systems and automation; Ensure consistent application of global CSV operating model; Lead and develop the regional CSV organization; Partner with cross-functional teams to achieve compliant outcomes; Drive inspection readiness and serve as CSV SME during audits
Seniority
Senior, hands-on IC with leadership scope