Document Control Training 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.

Job Location:
Nivagen Pharmaceuticals, Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:
The Document Control & Training Manager will support the development, delivery, and maintenance of training programs related to document control, ensuring compliance with industry standards like ISO, FDA, GMP, or GDP.They ensure that employees understand and follow document control processes, systems, and regulatory requirements, while also supporting audits and quality management initiatives.

Responsibilities:

Training Development & Delivery: Design and create training materials for QMS and document control processes; deliver instructor-led and virtual sessions across departments and sites.

Onboarding & Change Management: Provide onboarding training for new hires on document management and QMS procedures; support change initiatives by coaching and training impacted teams.

Training Effectiveness: Evaluate training outcomes, update content, and ensure alignment with industry standards.

Compliance Support: Maintain training records, track completion and competency, and provide documentation for audits to demonstrate compliance.

Curriculum & Reporting: Create/add curriculum assignments in the training system, generate reports, and distribute training results.

Cross-Functional Support: Partner with other departments to provide first-line training support and improve training programs.

Assist in the maintenance and continual improvement of the QMS, ensuring compliance with GMP, FDA, EMA, and other relevant regulatory standards

Manage QMS documentation, including the creation, revision, and archival of SOPs, quality manuals, and other controlled documents

Coordinate the implementation of changes controls to ensure systematic evaluation and documentation of changes affecting the QMS

Analyze quality data from various sources, including non-conformances, deviations, and CAPAs, to identify trends and areas for improvement

Generate detailed reports on QMS performance metrics, providing insights and recommendations to senior management

Monitor key performance indicators (KPIs) related to quality, such as defect rates, audit findings, and CAPA completion times

Assist in planning, conducting, and documenting internal audits to ensure compliance with the QMS and regulatory requirements

Support external audits conducted by regulatory agencies and clients, preparing necessary documentation and providing responses to audit findings

Track and follow up on audit findings to ensure timely and effective resolution, including the implementation of corrective and preventive actions

Stay current with changes in regulatory requirements and industry standards, ensuring that the QMS is updated accordingly.

Conduct periodic reviews of QMS documentation and processes to verify ongoing compliance with applicable regulations

Participate in risk assessments and contribute to the development of risk mitigation strategies within the QMS framework

Identify opportunities for improving quality processes and the overall QMS, recommending and implementing enhancements to increase efficiency and effectiveness

Lead or participate in root cause analysis for quality issues, ensuring that appropriate corrective and preventive actions are identified, implemented, and monitored for effectiveness

Provide training and support to staff on QMS processes, regulatory requirements, and quality improvement initiatives

Work closely with cross-functional teams, including Production, Quality Control, Regulatory Affairs, and Supply Chain, to ensure alignment on quality objectives and regulatory compliance

Collaborate with the Supplier Quality Management team to ensure that suppliers meet the company's quality standards and that the supply chain complies with GMP

Communicate effectively with internal stakeholders to provide updates on QMS activities, audit results, and continuous improvement initiatives

Review batch production records for completeness, accuracy, and compliance before product release, ensuring that all quality standards are met

Ensure proper control, accessibility, and regular review of all QMS documents, maintaining a high standard of documentation accuracy and compliance

Qualifications:

Bachelor's degree or equivalent combination of education and experience.

3-5 years in a regulated industry; preferred experience in project management, training, quality systems, or related fields.

Knowledge, Skills, and Abilities:

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).

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.

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