Manager, QA - Doc Control
Core
Lead the QA Document Control team across multiple production facilities to manage the lifecycle of GMP-controlled documents, procedures, and records, ensuring compliance with regulatory requirements.
Role type
Manager, QA Document Control
Builds
Controlled document systems (SOPs, Batch Records, Testing Data Sheets) and eQMS document modules for biopharma clients
Domain
Biopharma / GMP Quality Assurance
Required skills
GMP document control, eQMS administration, team leadership, internal auditing, regulatory compliance, process improvement, data analysis, SOP development, investigation management
Preferred skills
MasterControl experience, FDA-regulated environment experience
Technologies
eQMS, MasterControl
Responsibilities
Provide direction and oversight to the QA Document Control team across multiple facilities; Mentor and manage team members; Oversee the issuance, revision, and archiving of GMP-controlled documents; Serve as business process owner for the eQMS document module; Facilitate client approvals for Batch Records; Conduct internal audits of the eQMS document module; Support client audits and regulatory inspections; Identify and implement process improvements; Develop and maintain site-level metrics; Write and revise QA SOPs; Participate in investigations related to document control
Seniority
Manager, hands-on leadership
