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Senior Validation Manager
3 months ago
Responsibilities: Provide technical leadership for validation of Regulatory and Quality Systems used in R&D/commercial use of pharmaceutical products, ensuring compliance with internal policies/external regulations; as subject matter expert, ensure implementation of computerized system validation practices with focus on patient safety, product quality, and data integrity; support implementation of global Quality Systems, SaaS, and hosted computer systems; define technical direction on projects; develop/execute/approve validation documentation; set objectives and plan/execute tasks; conduct/approve risk assessments; support regulatory changes; assist in resolving compliance issues; prepare/present reports/SOPs; comply with cGMP, Safety & Environmental regulations, and company policies; assist in training/coaching staff.
Requirements: Bachelor's degree in Regulatory Affairs, Regulatory Information Management, or related field and seven years computer systems validation in pharmaceutical industry.*
Experience must include five years each of the following: supporting Enterprise Quality System Veeva and TrackWise Digital platforms; and experience in a team lead role. Experience must include three years each of the following: managing validation documentation in paperless validation system such as ValGenesis and Regulatory publishing/label management system; and implementing and maintaining compliance with GxP and FDA regulatory requirements related to computerized systems used in manufacture of pharmaceutical products. Experience may be gained concurrently.
*In the alternative, employer will accept Master's degree in Regulatory Affairs, Regulatory Information Management, or related field and five years of experience with computer systems validation in pharmaceutical industry.
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