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

• Becomes thoroughly knowledgeable of the applicable portions of Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) and maintains knowledge base on an ongoing, timely basis as procedural changes occur without relying on management intervention or direction.
• Ensures compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
• Adheres to company safety requirements.
• Proactively initiates the development of streamlined systems to effectively identify and resolve quality problems and process improvement opportunities.
• Lead or participate in cross-functional projects focused on system improvements, risk mitigation, and business process efficiency.
• Assists in internal audits and inspections of various departments/processes.
• Apply a structured methodology and lead change management activities. Leverage a change management methodology, process and tools to create a strategy to support adoption of the changes required by a project or initiative.
• Support communication efforts by enabling the design, development, delivery and management of key communications.
• Support and engage senior leaders through communication of KPIs, communication of key challenges, and when requesting for assistance in priorities and resistance management plan.
• Assess the change impact by conducting impact analyses, assess change readiness, and identify key stakeholders.
• Identify and manage anticipated and persistent resistance.
• Consult and coach project teams.
• Create actionable deliverables for the core change management plans: Sponsor Plan, People Manager Plan, Communications Plan, and Training Plan.
• Own and manage the Change Management System (CMS), ensuring compliance with 21 CFR 111, 21 CFR 117 (where applicable), NSF/GRMA, and other applicable quality and regulatory standards.
• Serve as the Subject Matter Expert (SME) for Change Control, ensuring the process is risk-based, efficient, and integrated with other quality systems (Document Control, Deviations, CAPA, Supplier Management, etc.).
• Lead the Change Control Review Board (CCRB) and the Change Control Collaboration (CCC) meetings, ensuring appropriate evaluation, risk assessment, impact analysis, stakeholder involvement, and documentation.
• Partner with cross-functional teams to ensure changes are properly scoped, justified, and approved prior to execution.
• Monitor change progress, ensure timely closure, and escalate delays or non-compliances.
• Maintain and optimize the electronic Change Control System (e.g., ETQ), including user support, training, and data integrity oversight.
• Analyze Change Control metrics, KPIs, and trends to drive continuous improvement, efficiency gains, and compliance enhancement.
• Support internal and external audits and regulatory inspections as the Change Control system SME.
• Train and coach stakeholders on Change Control procedures and best practices to promote a culture of quality and compliance.
• Coordinates and works with management and subject area experts in the planning for, and execution of regulated information technology capabilities to improve the operations, productivity and outcomes of Thorne’s Manufacturing and Quality functions and their day-to-day activities.
• Collaborates with in-house and third-party developers, quality assurance, quality control, production support, and others as required to provide technical direction on systems analysis, gathering of requirements, design, development, testing and deployment.
• Facilitates documentation of technical requirements, software design sessions, process workflow definitions and systems architectural reviews as well as implement necessary change control procedures.
• Ensures the timely and effective delivery of planned solutions into ongoing daily activities.
• Participates in technical advisory roles, as required.
• Coordinates and/or perform validation of various modules as they are implemented.
• Coordinates and facilitate user training for high impact software changes due to software upgrades.
• Ensures the effective handoff of final operating systems to appropriate parties for ongoing maintenance and troubleshooting.
• Becomes thoroughly knowledgeable of the Standard Operating Procedures (SOPs) for computerized software.

What You Need

• Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline.
• Minimum 3 years of experience in Quality Systems or Change Management within a regulated dietary supplement, pharmaceutical, or food manufacturing environment.
• 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 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.
• Adaptable and quickly respond to change.
• Math Ability: Employee has the ability to add, subtract, multiply, and divide in the units of measurement used in the Quality department, using whole numbers and decimals.
• Computer and Technical Skills: Employee has knowledge of Microsoft products such as Word, Excel, Visio and Power Point as well as the ability to learn other computer system. Employee has knowledge or ability to learn of project software (i.e., Go To Meeting, Zoom, Microsoft Team). Employee has knowledge or ability to learn scripting and markup languages (i.e., Python, SQL, JavaScript, HTML). Employee has knowledge or ability to learn reporting software (i.e., Tableau, Click, Power BI).

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

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