Manager, Document Control and Training

Key Responsibilities

• Support the full document lifecycle including creation, review, approval, distribution, revision, archival, and obsolescence.
• Ensure controlled documentation complies with all required internal requirements including formatting of controlled documents.
• Establish and maintain training matrices/curricula aligned to job functions.
• Create and manage training and document management metrics.
• Drive continuous improvement in training effectiveness (including onboarding, recurring training, and inspection preparedness) and document management processes.
• Achieve accurate training records and audit-ready traceability.
• Represent Document Control and Training at data reviews, including Management Review, highlighting trends, risks and improvement opportunities as requested.
• Maintain accurate logs and archives.
• Oversee document version control and support report generation.
• Support process and/or system related changes to the document management and training systems.
• Collaborate and follow up with cross-functional teams to gather and review documentation requirements, provide system/process specific support and gather and review areas of improvement.

Qualifications

• Bachelor’s degree and 5-8+ years of pharmaceutical/biotech R&D experience, including 3-5+ years of experience in Document Control.
• Experience administering training and documentation in Veeva Basics is a must.
• Strong administrative and organizational skills.
• Proficient in file and electronic data management systems.
• Excellent technical writing skills.
• Knowledge of records management principles and practices.
• Familiarity with document management software.
• Proficiency in using SharePoint and Microsoft Office applications required (MS Outlook, MS Word, MS Excel, MS PowerPoint).