Document Control & Training Manager

Kelly Science & Clinical is seeking a Document Control & Training Manager for a Direct Hire position at a leading specialty pharmaceutical company in Sacramento, CA. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.Salary: $80-90kOverviewIn this role, you will lead and mentor teams to manage document control and GMP training programs, ensuring regulatory compliance and inspection readiness, driving digital transformation, supporting cross-functional collaboration, and fostering a culture of continuous improvement and operational excellence within a fast-growing pharmaceutical and biotech organization.Schedule:Monday-Friday, standard working hoursResponsibilities:Lead and Develop Teams: Direct, mentor, and inspire the Document Control and GMP Training teams, fostering growth, accountability, and continuous improvement.Set Strategic Direction: Establish KPIs, objectives, and overall strategy for document control and training in alignment with organizational quality goals.Champion Regulatory ComplianceEnsure robust document management and training programs meet global regulatory requirements (21 CFR 210/211, EU GMP) and maintain inspection readiness.Oversee Document Lifecycle: Supervise the creation, organization, revision, archival, and retrieval of critical documents such as SOPs, Master Batch Records, and logbooks for multi-product/multi-site operations.Manage GMP Training Programs: Oversee employee training curricula, ensuring all staff are qualified, compliant, and prepared for evolving processes or regulatory changes.Drive Process Improvement: Proactively identify workflow bottlenecks, elevate document control best practices, and implement scalable solutions across the organization.Lead Digital Transformation: Act as the Business System Owner for electronic document and training management systems, overseeing system configuration, validation, and integrity per regulatory standards (21 CFR Part 11).Support Audits and Inspections: Represent quality systems during FDA/EMA audits, regulatory inspections, and customer visits, and deliver improvement strategies to leadership.Collaborate Cross-Functionally: Work closely with QA, Manufacturing, Regulatory, IT, and Engineering teams to drive seamless quality operations and support remediation efforts as needed.Uphold Culture and Standards: Set clear policies and productivity benchmarks, promote ethical practices, and cultivate a strong culture of operational excellence and compliance company wide.Qualifications: Bachelor's degree in Science, Engineering, or related field, Master's degree strongly preferred.8+ years of QA experience in a GMP-regulated environment.3+ years of people management experience.Extensive knowledge of cGMP (21 CFR 210/211), EU GMP, GDP, 21 CFR Part 11, and ALCOA data integrity principles.Demonstrated expertise as a Business System Owner for digital Document Control/Training systems.Proven experience supporting successful regulatory inspections and customer audits.Superior project management, change leadership, and communication skills.