Training and Doc Control Manager

About the Company

Nivagen is a global company dedicated to enhancing lives by developing and providing cost‑effective generic prescription drugs and over‑the‑counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare.

Through vertical integration of the pharmaceutical supply chain, cutting‑edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well‑being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry.

At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high‑quality, affordable medications while upholding the highest standards of integrity and excellence.

Nivagen Pharmaceuticals, Sacramento, CA

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.

• Leadership & Strategic Oversight
  • 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.
• Document Control Program Management
  • 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, 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.
• GMP Training Program Oversight
  • 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.
• Electronic Systems & Business System Ownership
  • 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,…