Sr Manager QA - Computer Systems Validation

Computer Systems Validation LeadOversight of facilities systems, utilities, process equipment, GxP validation and change management of computer systems compliance. The cross-functional role will work to drive continuous improvement across all GxP systems and equipment while serving as the primary point of contact for computer systems validation.This role can be based in Lexington, MA or San Diego, CA. Work schedule is 4 days in office and 1 day from home.Responsibilities:Serve as the quality lead for lab and process equipment design, qualification, and maintenance/calibration to ensure it remains in a state of controlSupport the Quality Management System (QMS) to monitor and improve processes within the GxP QMS frameworkIdentify and track progress against key project milestones partnering with applicable business process, equipment, and facilities owners along with any external providers to ensure overall project success and complianceWork effectively across the matrix by engaging with the broader process owner network and site or function process owners in designing and deploying systemsServe as the subject matter expert (SME) regarding data integrityAuthor Validation Plan, Design Specification, IQ, OQ & PQ Protocols, Traceability Matrix and Validation Summary Reports for assigned projectsManage authoring and dry running of IQ, OQ and PQ test scriptsDevelop preparation of all validation deliverables for approvalAuthor and manage resolution and final disposition of all deviations identified during test executionMaintain CSV master list and manage and carry out periodic company CSV reviewsSupport vendor audits and supplier approval process associated with CSVSupport computer systems Risk Based Assessment (RBA) and gap assessment remediation activitiesQualifications:A Bachelor's degree with 5+ years' pharmaceutical industry experiencePreviously served as SME for data integrityStrong knowledge of relevant Quality compliance processes and regulations (e.g., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP))Familiar with electronic quality system tools (e.g., Veeva Vault)Demonstrated system quality and compliance knowledge of GxP regulations (21 CFR Part 11, Annex 11 & GAMP5, etc.)