Training and Doc Control Manager

Job Location

3900 Duckhorn Dr, Sacramento, CA 95834

Title of the Position: Training and Document Control Manager

The Training and Document Control Manager provides strategic and operational leadership for the Document Control and GMP Training functions within the Quality Management System (QMS). This role ensures the organization maintains an inspection-ready, compliant, and scalable document management and training program aligned with cGMP (21 CFR 210/211), EU GMP, and applicable global regulatory requirements.

The Manager serves as a key Quality Systems leader, partnering cross-functionally to drive process standardization, digital system optimization, change management, and continuous improvement initiatives while fostering a strong quality culture.

• Lead and mentor the Document Control and Training teams, fostering accountability, transparency, and professional growth.
• Establish department objectives, performance metrics, and continuous improvement initiatives aligned with Quality strategy.
• Act as a strategic partner to Quality Leadership in both short-term execution and long-term QMS planning.
• Drive inspection readiness and serve as a visible leader during regulatory inspections and customer audits.
• Present quality system performance metrics and improvement plans to senior leadership.

• Oversee the global Document Control program to ensure compliance, scalability, and data integrity.
• Ensure proper organization, lifecycle management, archival, and retrieval of controlled documents.
• Lead the review, approval, and processing of SOPs, Master Batch Records, Protocols and reports, Forms and templates.
• Ensure timely issuance of document numbers, logbooks, batch records, and quality record identifiers.
• Maintain workflow oversight to drive on-time document review and approval.
• Evaluate and improve document control processes to support multi-product and multi-site operations.
• Conduct internal audits of document control processes to ensure compliance and effectiveness.

• Manage and enhance the site GMP Training Program to ensure regulatory compliance and workforce competency.
• Ensure training curricula align with controlled document changes and organizational change management.
• Partner with functional leaders to ensure appropriate assignment and completion of role-based training.
• Monitor training compliance metrics and address overdue or non-compliant training events.
• Support qualification and retraining programs in manufacturing and quality operations.

• Serve as Business System Owner (BSO) for electronic Document Management and Training Systems (e.g., Compliance Wire, eInfoTree).
• Oversee system configuration, metadata management, access controls, and periodic reviews.
• Support QMS system enhancements, validation (CSV), and digital transformation initiatives.
• Lead requirement‑gathering sessions for system improvements and scalability.
• Ensure data integrity and regulatory compliance within electronic systems.

• Ensure alignment with cGMP, GDP, 21 CFR Part 11, EU GMP, and applicable regulatory standards.
• Support regulatory inspections, internal audits, and customer audits related to document control and training.
• Provide QMS metrics and reports to support Management Review.
• Collaborate cross-functionally (QA, Manufacturing, Regulatory, IT, Engineering) to ensure consistent quality process execution.
• Support remediation activities, including high-volume SOP updates under accelerated timelines.
• Promote continuous improvement and operational excellence within Quality Systems.

• Directly manage and develop Document Control and Training personnel.
• Set performance goals and conduct regular performance evaluations.
• Develop policies, procedures, and productivity standards.
• Allocate resources and prioritize workload to meet business needs.
• Foster cross-functional collaboration and effective communication across departments.
• Ensure department operates to the highest ethical and compliance standards.

• Bachelor’s…