Greenville, SC, 29602, USA
27 days ago
Director of Quality Assurance
**Company Description** As the global leader in health and wellness innovation since 1935, GNC motivates people to reach their goals with the most trusted and exciting selection of products in the industry. As #TeamGNC, we work hard to ensure that our consumers come first. We are always cultivating and collaborating on new ideas to bring innovative solutions to the forefront and testing new solutions to translate goals into action. Our team members are advocates for change and innovation. There is no greater gift than good health and no greater satisfaction than helping others to achieve it. Be a part of helping others to Live Well! **Job Description** **What We’re Looking For:** At GNC we embrace a “Live Well” philosophy, fostering a dynamic environment where innovation meets passion. Whether someone is an athlete or just starting to focus on their health, we want to deliver the cutting-edge products they deserve. We are looking for an individual who is excited and eager to play a pivotal role in driving excellence in the health and wellness industry. This position offers the opportunity to engage in a collaborative environment where you will make a personal impact every day. **What You’ll Do:** **This is a Full-Time Salary Position** The Quality Assurance Director will be an integral role in the management of critical quality activities including GNC Supplier Qualification and Management, Deviation Management, Change Control Management, Complaint Management, CAPA Management, Continuous Improvement, and Administration of GNC’s EQMS software. Additionally, this individual will serve as GNC’s Recall Coordinator, being the primary point of contact for Regulatory Bodies/Authorities in the event of a Market Action Event or Inspection of GNC, as well as a Preventative Control Qualified Individual (PCQI) to manage aspects of GNC Foreign Supplier Verification Program (FSVP) as required by 21 CFR Part 117. Supervise the collection of all international franchise receivables. + Owner and Primary Administrator of GNC’s EQMS system. This includes system enhancement development and customization. + Develop documentation architecture and hierarchy and establish workflows for all Quality processes. + Develop and maintain the GNC Supplier Database in the EQMS System Ensure compliance of credit policies prior to the shipment of orders to International franchisees. + Manages all Document Control activities company-wide including the creation, revision, and obsolescence of Standard Operating Procedures (SOPs), Work Instructions, Controlled Forms, Manuals, Master Plans, Position Papers, Global Quality Standards and all training documentation for the operation, use, and maintenance of GNC Systems. + Oversee the Management of Internal and External Deviation Requests in both the EQMS and other ancillary routing systems for review and approval. + Serve as liaison and oversee audits of GNC suppliers that are sponsored by strategic partners as a prerequisite condition of due diligence within the scope of the approved business agreement. + Plans and performs audits of GNC Suppliers (New and Existing) according to the requirements as specified in the respective quality Auditing includes New/Qualification Audits, Desktop Audits, For-Cause Audits, Virtual Audits, On-Site Audits, and routine GMP Surveillance Audits and Requalification activities. **SUPERVISORY RESPONSIBILITIES::** + Responsible for supervising multiple projects + Responsible for supervising multiple direct reports and their activities **Environmental Factors & Working Schedule:** + Hybrid work environment, 3 days in-person attendance in addition to ability to work remotely. + Regularly required to stand; walk; sit; use hands or fingers to handle or feel; reach with hands and arms; stoop, kneel, crouch, or crawl; and talk or hear + Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading. + Work is performed in an office environment and requires the ability to operate standard office equipment and keyboards. + Specific vision abilities required by this job include long periods of computer screen usage, close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus + The noise level in the work environment is usually low/moderate _* Reasonable accommodations may be made to enable individuals to perform the essential functions._ **QUALIFICATIONS:** + Bachelor’s Degree in Science or related field; or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job required + Advanced degree (MBA, Master’s) preferred + ASQ Certifications are preferred (Certified Quality Auditor) + Certification as a Preventative Controls Qualified Individual (PCQI) + 10+ years in FDA regulated Industry, preferably Dietary Supplements and/or Food required + 8+ years in a leadership role dealing with cross-functional internal and external stakeholders. + Subject Matter Expert in Good Manufacturing Practice Regulations, FDA Labeling regulations, CPSC and USDA regulations as applied to Foods and Dietary Supplements **Benefit Offerings** Benefit Offerings: Medical, Dental, Vision, STD, LTD, Paid Company Life Insurance, 401K program with company match, 30% employee merchandise discount on GNC products & 20% employee discount on 3rd party products, Monthly Free Product Offers, and access to the Employee Assistance Program. GNC Holdings LLC is an Equal Opportunity Employer
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