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

About GNC

Since 1935, GNC has been a global leader in health and wellness innovation, inspiring people to achieve their goals with a trusted and dynamic range of products. As #TeamGNC, we prioritize our consumers, constantly collaborating and developing new ideas to deliver cutting-edge solutions. Our team is passionate about driving change and turning aspirations into actions. We believe that good health is the greatest gift, and there's nothing more rewarding than helping others achieve it. Join us in empowering others to Live Well!

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 Hourly 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.

The Quality Assurance Director will be responsible for managing the Quality Assurance and Quality Control due diligence across GNC’s entire Supplier base. This includes developing risk management systems to evaluate and assess each supplier so that appropriate levels of prevention and appraisal resources can be applied effectively to those suppliers that carry the highest risk of enforcement action. This individual will be a Quality Management System representative for all GNC-branded product development projects and will work with GNC Product Development teams to ensure that Quality By Design elements are built into the product. Along with GNC Legal, this individual will be responsible for the creation and maintenance of Supplier Quality Agreements and/or Continuing Product Guarantees to ensure that each GNC-Branded Product Supplier is aware of their obligations to GNC. Responsible for performing the Qualification Activities required per Good Manufacturing Practice Regulations for New Suppliers and ongoing Requalification due diligence.

This individual will support critical compliance elements of EQMS implementation including Application Security, Data Security, Infrastructure Security, Software Security Practices, Compliance to FDA’s Computer Systems Validation Code (21 CFR Part 11), and Information Securities Policy. This individual will be a Functional Power User and the Administrator of the system across all GNC internal and any external stakeholders. This responsibility will include identity and access management, audit trails and user authorization credentials.

In this role, the Quality Assurance Director will oversee the management activities for critical to quality elements such as Deviations (Planned/Unplanned), Change Controls, Corrective Action/Preventative Action (CAPA), and Complaints (GNC and Third-Party, including AERs/SAERs). This individual will be a key stakeholder in the review, processing, and approval of the aforementioned activities.

Additionally, this role will support the multiple business units to service omni-channel and alternate sales channel opportunities to increase the presence of GNC products throughout the US and other countries. This individual will serve as a technical liaison and will present GNC’s Standards for Quality and Compliance to strategic partners through the exchange of critical compliance documentation. This individual will provide technical documentation to GNC’s strategic partners, including retailers, and ensure that the technical documentation meets all regulatory and compliance standards including but not limited to, Good Manufacturing Practice regulations, Labeling regulations, Proposition 65, Consumer Product Safety Commission Standards, and USDA Standards.

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

• Advanceddegree (MBA,Master’s) preferred

• ASQCertificationsarepreferred(CertifiedQualityAuditor)

• CertificationasaPreventativeControlsQualifiedIndividual(PCQI)

• 10+yearsinFDAregulatedIndustry,preferablyDietarySupplementsand/or Foodrequired

• 8+yearsin a leadership role dealingwith 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

• Abilitytoreview proposed regulations and work with stakeholders to address upcoming regulatory

• Working knowledgewithElectronic SystemsincludingLIMS,ERP, EQMS,andWorkfront

• High degreeofproficiencyMSOfficeSuite, Outlook&Internet applications

• Strong analytical, prioritizing, interpersonal, problem-solving, presentation, budgeting, project management (from conception to completion), & planning skills

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