Manager, Document Control and Training

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Assist with the complete document lifecycle, encompassing creation, review, approval, distribution, revision, archival, and obsolescence.

• Ensure that controlled documentation adheres to all necessary internal standards, including the formatting of controlled documents.

• Manage the routing of documents for signatures, ensuring all requirements are fulfilled.

• Develop and uphold training matrices/curricula that are aligned with job functions.

• Create and oversee training and document management performance metrics.

• Promote continuous enhancement in training effectiveness (including onboarding, recurring training, and inspection readiness) and document management processes.

• Guarantee the accuracy of training records and maintain audit-ready traceability.

• Represent Document Control and Training during data reviews, such as Management Review, by highlighting trends, risks, and opportunities for improvement as needed.

• Ensure that documents are systematically organized, stored, and accessible to authorized personnel.

• Maintain precise logs and archives.

• Supervise document version control and assist in report generation.

• Support process or system-related changes to the document management and training systems.

• Collaborate and follow up with cross-functional teams to gather and assess documentation requirements, provide system/process-specific support, and identify areas for improvement.

⛳️ Requirements

• Bachelor’s degree with 5-8+ years of experience in pharmaceutical/biotech R&D, including 3-5+ years specifically in Document Control.

• Proven experience in administering training and documentation in Veeva Basics is essential.

• Strong administrative and organizational abilities.

• Proficient in managing files and electronic data management systems.

• Excellent skills in technical writing.

• Understanding of records management principles and practices.

• Familiarity with document management software.

• Required proficiency in using SharePoint and Microsoft Office applications (MS Outlook, MS Word, MS Excel, MS PowerPoint).

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• Collaborative and innovative work environment.