Job Description

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.

Job Location:

Nivagen Pharmaceuticals, Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:

Nivagen Pharmaceuticals is seeking a Document Control & Training Manager to lead the document control and GMP training programs across all quality and manufacturing operations. This is a managerial role responsible for overseeing SOP lifecycle management, training program development and execution, regulatory compliance of controlled documents, and supervision of Document Control Specialists and Training Coordinators within a sterile pharmaceutical manufacturing environment. The ideal candidate is a hands-on leader who can build scalable document control and training systems from the ground up while maintaining compliance with FDA/cGMP and ICH requirements.

Responsibilities:

• Lead and manage the document control team, including supervision of Document Control Specialists and Training Coordinators.
• Own the SOP lifecycle from drafting through review, approval, issuance, periodic review, and retirement across all GMP departments.
• Establish and maintain the controlled document hierarchy (policies, SOPs, work instructions, forms, batch records) in compliance with 21 CFR Part 211 and ICH Q10.
• Manage the electronic document management system (eInfotree or equivalent), including user access, document workflows, version control, and archival.
• Develop, implement, and manage the site-wide cGMP training program including new hire orientation, role-based training curricula, annual retraining, and training effectiveness assessments.
• Ensure training records are complete, accurate, and audit-ready; maintain training matrices for all GMP personnel.
• Lead the SOP Harmonization Program, coordinating batch scheduling and reviews across Validation, Microbiology, DEA, SAP, and other functional groups.
• Track and report document control and training KPIs including SOP revision cycle time, overdue training, training completion rates, and document backlog metrics.
• Support internal audits and FDA/regulatory inspections by providing training records, controlled document packages, and SOP status reports.
• Collaborate with QMS management on quality council presentations, management review inputs, and continuous improvement initiatives.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Engineering, or a related field.
• Minimum 7–10 years of experience in QA, managing document control and training programs in sterile pharmaceutical manufacturing, with at least 2 years in a supervisory or managerial role.
• Strong knowledge of 21 CFR Parts 210, 211, and 212; ICH Q7 and Q10; and FDA expectations for controlled documents and training systems in sterile manufacturing environments.
• Experience with electronic document management systems (eInfotree, TrackWise or similar).
• Proven experience developing and managing GMP training programs specific to sterile and aseptic operations, including gowning qualification, aseptic technique training, and cleanroom behavior.
• Excellent organizational and project management skills with the ability to manage multiple concurrent SOP review and training initiatives.
• Strong written and verbal communication skills with the ability to author clear, compliant SOPs and training materials.
• Experience leading SOP harmonization or standardization projects across multiple departments.
• Experience supporting FDA or regulatory inspections is a plus.

Job Requirements:

• The role involves working in both office and manufacturing environments, requiring adherence to safety protocols and GMP standards
• Occasional travel may be required for audits, supplier evaluations, or training
• Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles’ radius)
• Familiarity with regulatory standards (ISO, FDA, GMP, GDP).
• Strong presentation, communication, and facilitation skills.
• Problem-solving and proactive approach to challenges.
• Excellent organization and attention to detail.
• Proficiency in Microsoft Office and Learning Management Systems (LMS).

Benefits:

• Pay range: $90- $140K based upon experience
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
• Medical, dental, and vision coverage
• Paid time off plan

Additional Information:

Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.