What are the responsibilities and job description for the QUALITY SOFTWARE COMPLIANCE MANAGER position at Thorne Research Inc?
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 Quality Software Compliance Manager is responsible and accountable for all new and existing regulatory software systems used at Thorne’s manufacturing locations. The Quality Software Compliance Manager oversees 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. The Quality Software Compliance Manager must be able to lead and work with cross-functional teams and track projects to completion. This position requires experience in cGMP manufacturing environment plus demonstrate familiarity with software regulatory compliance and validation, quality concepts, practices, and procedures.
RESPONSIBILITIES – Satisfactorily performing and/or achieving the following Responsibilities are essential duties of the job.
- 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.
- Mentors associates and foster a learning and growth environment. • Ensures compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company
What You Need:
- Education and Experience: By training, education, and/or experience, must be able to perform the essential duties of their job. 4-year college degree with four to eight years related experience; or equivalent combination of education and experience is required.
- 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).
- Experience in an FDA regulated environment and familiarization with Quality Management processes, computerized software systems and terminology is required.
- Experience with computerized software development and validation life cycle is required.
- Experience with Quality Management, Laboratory Information Management, Learning Management, Manufacturing, and Electronic Batch Records software systems
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
- A safe and clean work environment
A little bit more about us.
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
If you want to make a difference in the lives of others consider becoming part of the Thorne team.
