CQV Lead

Job Title: CQV Lead Consultant Location: Remote Job Description:We are seeking an experienced CQV Lead Consultant to support a large-scale ATMP manufacturing greenfield project. The ideal candidate will have strong leadership experience managing CQV activities for pharmaceutical or biotech CAPEX projects and overseeing the full validation lifecycle within GMP-regulated environments. Key Responsibilities:Author and manage Validation Master Plans (VMP)Develop validation SOPsSupport development of System Activity Matrices (SAM)Review System Impact Assessments (SIA)Review User Requirement Specifications (URS)Review Requirements Traceability Matrices (RTM)Review Computerized System Impact Assessments (CSIA)Support Master Equipment List (MEL) activitiesDevelop System Level Validation PlansConduct Data Integrity AssessmentsLead Cx/IQ/OQ activities including protocol generation, review, approval, execution, and summary reportingSupport qualification and validation activities for equipment, facility systems, and computerized systems (excluding BMS & EMS)Required Experience:Experience leading CQV teams on large-scale greenfield pharmaceutical or biotech projectsStrong understanding of commissioning, qualification, and validation processesExperience managing validation strategy and lifecycle activitiesKnowledge of GMP regulations and compliance standardsAbility to work with cross-functional teams and stakeholdersPreferred Qualifications:ATMP manufacturing facility experienceModular cleanroom experienceFamiliarity with FDA, EMA, and SFDA regulatory requirements