Senior Design Verification Lead

. Design Verification Program LeadershipDevelop, implement, and maintain the Design Verification (DV) framework for facility, equipment, automation, and process changes.Ensure alignment with GMP, ICH Q8-Q11, FDA, EMA, and ISPE Baseline Guide expectations for biologics manufacturing.Author and approve DV plans, protocols, reports, traceability matrices, and risk assessments.Serve as a Technical Lead an design verification authority for designated scopes in support of a new site facility build out. Design Verification Program LeadershipDevelop, implement, and maintain the Design Verification (DV) framework for facility, equipment, automation, and process changes.Ensure alignment with GMP, ICH Q8-Q11, FDA, EMA, and ISPE Baseline Guide expectations for biologics manufacturing.Author and approve DV plans, protocols, reports, traceability matrices, and risk assessments.Serve as a Technical Lead an design verification authority for designated scopes in support of a new site facility build out