Manager, Clinical Program Documentation Control and Audit Readiness
Core
Manage clinical procurement documentation control, audit readiness, and evidence retrieval for CPSC activities to ensure compliance with regulatory inspections and quality reviews.
Role type
Manager, Clinical Program Documentation Control and Audit Readiness
Builds
Procurement records, audit response playbooks, SOPs, and inspection-ready documentation packages
Domain
Biotechnology/Pharmaceuticals (Clinical Sourcing and Contracting)
Required skills
Project management, documentation control, SOP development, SharePoint governance, stakeholder coordination, risk identification, process improvement
Preferred skills
Regulated clinical development environment knowledge, audit/inspection support experience, Lean Six Sigma (Green Belt)
Responsibilities
Coordinate audit readiness and inspection support for procurement activities; retrieve and package procurement records for submissions; partner with Quality, Legal, and Regulatory teams; develop reusable audit response playbooks and training materials; identify documentation gaps and drive remediation; represent CPSC in continuous improvement initiatives.
Seniority
Manager, hands-on leadership