Document Control and GMP Training Manager Job Listing at Kelly Services in Sacramento, CA (Job ID 10142898)

Description

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.
Position Title: Document Control and GMP Training Manager
Position Type: Direct hire
Salary range: $80,000-90,000
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.
Key Responsibilities:
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., ComplianceWire, 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.

What You Bring:

• 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 skills.

Preferred Experience:

• Record of scaling document control for multi-product/multi-site organizations.
• Track record of leading QMS/digital transformation or major system implementations (Veeva certification a plus).
• Strong change management and organizational skills; thrives in dynamic, high-growth environments.

Why Sacramento? Why Us?

• Join a vital, collaborative team at the forefront of Sacramento's life sciences renaissance.
• Opportunity to shape, improve, and scale quality systems in a growth-focused organization.
• Build your legacy in a region brimming with career advancement and community impact.

Work Environment:

• Primarily on-site, engaging cross-functionally with leaders and staff across the company.
• Standard day shift, with flexibility to respond to audits, inspections, or major projects as needed.

Ready to put your expertise and leadership to work in one of Northern California's most dynamic pharma sectors? Apply today and help drive Sacramento's life sciences future!
#P1

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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