Document Control and GMP Training Manager

Kelly® Science & Clinical is seeking a Document Control and GMP Training Manager for a direct hire opportunity with a leading specialty pharmaceutical company in Sacramento, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.

** Workplace:
** Onsite in Sacramento, CA.

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* Position Title:

** Document Control and GMP Training Manager

** Position Type:
** Direct hire

** Salary range** : $80,

** Overview*
* Advance your career in Sacramento's fast-growing pharmaceutical and biotech sector by joining our team as a Training and Document Control Manager. In this high-impact leadership role, you'll champion quality, compliance, and workforce readiness-elevating our organization's standards and supporting innovation in a region known for its thriving life sciences community.

** Your Mission:*
* As a key leader in our Quality organization, you will shape and sustain robust Document Control and GMP Training programs, ensuring we remain inspection-ready and in full alignment with global cGMP standards (21 CFR 210/211, EU GMP). You'll drive process improvements, digital transformation, and a culture of operational excellence while mentoring and empowering your teams.

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* Key Responsibilities:

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* Strategic Leadership & Quality Guidance

+ Lead, inspire, and develop Document Control and GMP Training teams-fostering a culture of growth, accountability, and continuous improvement.

+ Set strategic direction, KPIs, and objectives in line with overall Quality goals.

+ Serve as a crucial partner for Quality Leadership, supporting both immediate needs and long-term QMS initiatives.

+ Champion inspection readiness, representing Quality Systems during FDA/EMA visits, customer audits, and senior leadership reviews.

+ Present quality performance metrics and improvement strategies to executive leadership.

World-Class Document Control

+ Oversee the lifecycle of critical documents-SOPs, Master Batch Records, forms, logbooks, and more-across multi-product and potential multi-site operations.

+ Safeguard document integrity, compliance, organization, archival, and retrieval, ensuring global regulatory requirements are met.

+ Drive timely document workflows, reviews, and approvals while proactively identifying and eliminating process bottlenecks.

+ Continuously audit and elevate document control processes for scalability and best-in-class compliance.

+ Lead rapid, large-scale document revisions and updates to support business expansion and regulatory needs.

Cutting-Edge GMP Training Management

+ Strategically manage the GMP Training program, ensuring every employee is prepared, competent, and compliant.

+ Align training curricula with document/process changes and organizational growth.

+ Partner with functional leaders to drive timely completion of role-based training and support ongoing qualifications or retraining in manufacturing/quality functions.

+ Monitor training metrics, address compliance gaps, and champion a culture of learning and development.

Digital Transformation & System Leadership

+ Act as the Business System Owner (BSO) for electronic Document Management and Training systems (e.g., Compliance Wire, eInfoTree, or Veeva).

+ Oversee system configuration, user access, metadata management, and system validation to maintain data integrity and regulatory alignment (21 CFR Part 11, GDP, ALCOA).

+ Lead digital initiatives to scale and optimize QMS platforms for Sacramento and beyond.

Collaboration, Compliance & Excellence

+ Collaborate with QA, Manufacturing, Regulatory, IT, and Engineering-driving seamless execution of quality processes.

+ Support internal/external audits, regulatory inspections, and fast-tracked remediation projects.

+ Provide actionable QMS metrics, periodic reports, and insights to enable informed business decisions.

Team Management & Cross-Functional Partnership

+ Directly manage, coach, and grow your team-setting clear goals, conducting performance reviews, and building high-performing talent.

+ Develop and uphold clear policies, procedures, and productivity standards.

+ Promote open communication and interdepartmental collaboration to advance a strong quality culture.

+ Operate with the utmost integrity and ethical standards.

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* What You Bring:

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* + Bachelor's degree in Science, Engineering, or related discipline (Master's strongly preferred).

+ 8-10 years' quality assurance experience in a GMP-regulated pharmaceutical or biotech environment.

+ 3-5 years' successful people management and leadership 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…