Change Management Systems Manager Job at Thorne Research Inc, Summerville, SC

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  • Thorne Research Inc
  • Summerville, SC

Job Description

Job Description

Job Description

At Thorne we make products that matter - ones that make people's lives better. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you’ll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions.

Position Summary: The Change Management Systems Manager is responsible for overseeing and continuously improving the company’s Change Control program to ensure compliance with applicable FDA, cGMP, NSF/GRMA, and international regulatory requirements governing dietary supplements. This role ensures that all product, process, packaging, labeling, and documentation changes are evaluated, approved, implemented, and monitored in a controlled, compliant, and efficient manner.

This position will collaborate cross-functionally with R&D, Quality, Regulatory, Operations, and Supply Chain teams to ensure timely and risk-based change implementation that supports business objectives while maintaining regulatory compliance. It will oversee the planning for and execution of technical application design, configuration, testing, implementation, and on-going application support and compliance for the software lifecycle. This position provides support to personnel who implement, support, and validate new and existing regulated software systems.

Responsibilities

  • Own and lead the Change Management System (CMS), ensuring compliance with FDA, cGMP, NSF/GRMA and international regulations.
  • Manage all changes to product, process, packaging, labeling, and documentation in a timely, risk-based, and traceable manner.
  • Serve as SME for Change Control, leading the Change Control Review Board (CCRB) and driving cross-functional collaboration.
  • Partner with R&D, Quality, Regulatory, Operations, and Supply Chain to scope, justify, and implement compliant change initiatives.
  • Maintain and optimize the electronic Change Control System, ensuring data integrity, user support, and process efficiency.
  • Track KPIs and risk assessments to monitor progress, escalate issues, and drive continuous improvement.
  • Represent the Change Control system during audits and inspections with credibility and confidence.
  • Oversee validation, documentation, and smooth transition of regulated software systems into daily operations.

What You Need

  • Bachelor’s degree in Life Sciences, Quality, Regulatory, Industrial Engineering or related discipline is preferred.
  • Minimum 3 years of experience in Quality Systems or Change Management within a regulated dietary supplement, pharmaceutical, or food manufacturing environment is preferred.
  • 3 years of experience managing electronic Change Control Systems (e.g., ETQ) and associated reporting tools.
  • Experience with software development life cycle preferred.
  • Project Management Certification and Six Sigma Certification preferred.
  • Ability to manage multiple projects from beginning to completion.
  • Possesses the ability to deliver on assigned objectives within requested timeframes.
  • Strong analytical skills to solve complex problems providing possible outcome and look for concrete research before forming opinions.
  • Ability to understand the team’s challenges and develop solutions.

What We Offer

At Thorne, we offer employees the chance to work with great people on exciting projects, with opportunity for growth. We also provide a full range of benefits for you and your eligible family members, such as:

  • Competitive compensation
  • 100% company-paid medical, dental, and vision insurance coverage
  • Company-paid short- and long-term disability insurance
  • Company- paid life insurance
  • 401k plan with employer matching contributions up to 4%
  • Gym membership reimbursement
  • Monthly allowance of Thorne supplements
  • Paid time off, volunteer time off and holiday leave
  • Training, professional development, and career growth opportunities

Thorne is the leader in science-backed health and wellness solutions committed to helping individuals live healthier longer. As the top recommended clinical brand by healthcare practitioners, Thorne offers a comprehensive range of products including nutritional supplements and health tests designed to meet the unique needs of individuals at every stage of life. Founded in 1984, Thorne products are formulated with the highest-quality ingredients, supported by clinical research, and rigorously tested to ensure purity, potency, and efficacy. Thorne is the only supplement manufacturer that collaborates with Mayo Clinic on health and wellness research and content and is trusted by 47,000+ health-care professionals, thousands of professional athletes, more than 100 professional sports teams, multiple U.S. National Teams, and more than five million consumers. For more information, visit Thorne.com

THORNE IS AN EQUAL OPPORTUNITY EMPLOYER

#LI-SC1

Job Tags

Temporary work,

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