Manager, QA - Doc Control
About The Position
The QA Manager – Document Control leads the QA Document Control team across multiple production facilities in a regulated GMP environment. The role ensures effective management and lifecycle maintenance of controlled documents, procedures, and records in compliance with internal policies and external regulatory requirements. It also drives strategic improvements to document control systems, mentors staff, and promotes a collaborative work culture. The position oversees the issuance, revision, and archiving of GMP-controlled documents; owns and administers the eQMS document module; supports client approvals and periodic SOP reviews; and helps ensure documentation readiness for audits and regulatory inspections. The manager develops and analyzes performance and compliance metrics, identifies process improvements, writes and revises QA SOPs, and participates in investigations related to document control activities. The role requires effective communication, the ability to manage multiple projects in a complex environment, prolonged sitting or standing, and occasional lifting of up to 20 pounds. Occasional travel of approximately 10% is required. Work takes place in secure document-control filing rooms, a standard office setting, and occasionally in cleanroom or production facility areas.
Requirements
- Bachelor's degree in a related field and 5–8 years of relevant experience in an FDA-regulated environment; alternatively, a high school diploma or associate degree with 10+ years of GMP experience.
- At least 5 years of Document Control experience.
- Experience with an electronic Quality Management System.
- Ability to communicate effectively through speech, vision, hearing, and written communication.
- Ability to manage multiple projects simultaneously in a complex environment.
- Ability to sit or stand for prolonged periods and occasionally lift up to 20 pounds.
- Ability to travel occasionally, approximately 10%.
Nice To Haves
- MasterControl experience.
Responsibilities
- Provide direction and oversight to the QA Document Control team across multiple facilities.
- Mentor and manage team members, supporting professional development and a collaborative, high-performing culture.
- Communicate clearly, concisely, and promptly with senior management and cross-functional teams.
- Oversee issuance, revision, and archiving of GMP-controlled documents, including Batch Records, Testing Data Sheets, Equipment Log Books, and Quality System documents.
- Serve as business process owner and administrator for the eQMS document module, driving continuous improvement and system optimization.
- Facilitate client approvals for Batch Records and manage periodic SOP reviews with stakeholders.
- Conduct internal audits of the eQMS document module for compliance with regulatory and organizational requirements.
- Support client audits and regulatory inspections by ensuring documentation readiness.
- Collaborate with cross-functional teams on document control in alignment with broader business objectives.
- Identify and implement process improvements to enhance efficiency, compliance, and effectiveness within QA operations.
- Develop and maintain site-level metrics for QA Document Control activities.
- Analyze data for trends, gaps, and improvement opportunities, and share actionable insights with leadership.
- Track and report compliance metrics, including training completion rates, document approval timelines, and audit findings.
- Write and revise QA SOPs related to document control processes.
- Participate in investigations related to document control activities and recommend corrective actions.
- Perform other duties as assigned by senior management.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
