Training and Doc Control Manager
2 days ago
Sacramento
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: 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. Responsibilities: * 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., • 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., • 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., • Serve as Business System Owner (BSO) for electronic Document Management and Training Systems (e.g., ComplianceWire, 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 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., • 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., • Bachelor's degree in Science, Engineering, or related technical discipline (Master's degree preferred)., • Minimum 8–10 years of experience in Quality Assurance within a GMP-regulated pharmaceutical or biotech environment., • 3–5 years of direct people leadership experience., • In-depth knowledge of:, • cGMP (21 CFR Parts 210/211), • EU GMP, • Good Documentation Practices (GDP), • 21 CFR Part 11, • ALCOA and Data Integrity, • Demonstrated experience as Business System Owner for electronic Document Control and/or Training systems., • Experience supporting regulatory inspections and audits., • Strong organizational, analytical, and strategic planning skills., • Excellent written and verbal communication skills., • Strong understanding of pharmaceutical regulations, including FDA, EMA, GMP, and ICH guidelines, • Proficient in data analysis with the ability to interpret complex quality data and identify trends, • High level of accuracy and attention to detail, particularly in documentation and data analysis, • Demonstrated ability to conduct root cause analysis and implement effective CAPAs, • Excellent written and verbal communication skills, with the ability to prepare clear and concise reports and documentation, • Familiarity with QMS software and other relevant tools used in quality management and data analysis, • 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) Additional Information: • Flexibility is required as work hours and start times may vary to provide coverage on different shifts to meet business needs., • Overtime and weekend work may be required., • Pay range Competitive, • Yearly bonus eligibility, • 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 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.