Document Control Manager

Job Summary

To lead and manage the company's document control systems, the full-time Document Control Manager will ensure compliance with GMP and regulatory requirements, oversee document creation and maintenance, and manage training records, with a preference for candidates based in the Bay Area but also considering remote applicants within the United States.

Key responsibilities

• Own and manage the document control program, ensuring compliance with GMP, GCP, and regulatory requirements
• Develop and maintain document control procedures, workflows, and best practices, including the creation and publication of controlled documents
• Maintain employee training records and coordinate training associated with new or revised controlled documents

Required qualifications

• BS/MS degree in Life Sciences, Biotechnology, or a related discipline
• 5-8+ years of document control experience within a regulated GMP environment
• Experience managing controlled documents throughout their lifecycle
• Working knowledge of FDA, ICH, and GxP regulations related to document management
• Proficiency with Microsoft Office applications and document management systems