Commissioning & Qualification (C&Q) Documentation Lead

We are seeking a Commissioning & Qualification (C&Q) Documentation Lead to support GMP-regulated pharmaceutical manufacturing projects. This role is responsible for independently developing, authoring, and managing all commissioning and qualification documentation from initiation through final approval.Key Responsibilities:Independently draft, develop, and finalize C&Q documentation including protocols, reports, and supporting records from concept to approvalAuthor and manage Change Control documents (CLIAs) related to C&Q activities in alignment with GMP and site proceduresDevelop User Requirement Specifications (URS) and ensure alignment with project and regulatory expectationsLead technical discussions and negotiations with external vendors to resolve documentation, scope, and execution issuesCollaborate effectively with cross-functional teams including engineering, QA, validation, and operationsSupport large-scale CAPEX projects with the ability to manage multiple priorities in a fast-paced environmentRequired Experience & Skills:Strong experience in GMP/Pharma manufacturing environmentsProven ability to write C&Q documentation from scratchExperience with Change Controls (CLIAs) and URS developmentExposure to CAPEX / large capital projectsStrong stakeholder management and vendor coordination skillsAbility to work independently and drive deliverables across multiple teams