Job Description
Director of Compliance
Job Summary:
Responsible for global product regulatory compliance affecting all private-label and third-party products in all markets. Possesses knowledge of domestic and international regulations affecting conventional foods (food supplements), dietary supplements and OTC drugs. Reporting to the Chief People Officer, the Director of Compliance & Quality Control will be tasked with overseeing product and digital onboarding and maintaining the salability of all private-label, 3rd party and digital products from a regulatory compliance and quality perspective. Working closely with internal departments and product vendors, the Director will ensure that formulae, labeling, marketing claims, manufacture and distribution comply with local and international laws and regulations.
Roles and Responsibilities:
- Utilizes expertise and research of domestic and international laws and regulations to maintain and update the Country Restriction Tool (CRT) to prevent distribution of ingredients to countries, states, or regions for which they are not permitted in the intended product.
- Conducts timely and enhanced regulatory reviews to support the widest possible commercialization of private-label and 3rd party products. As part of the on-boarding process, compliance will review private-label and 3rd party products: (a) full disclosure formulae; (b) proposed claims; (c) proposed labeling; (d) proposed cautionary/warning labeling; (e) proposed on-line portal copy; (f) packaging inserts and articles; (g) componentry; (h) manufacturing records; (i) safety and efficacy substantiation; (j) post-marketing surveillance information; and (k) indications of any current or recent government action/s involving the third-party vendor and their product/s.
- Responsible for proactively managing the companys global quality assurance and quality control functions to ensure compliance with regulatory requirements including: (a) current Good Manufacturing Practices; (b) consumer-generated product complaints and analyses; (c) post-marketing surveillance (including the receipt, medical analysis, and reporting of adverse event and serious adverse event reports); (d) stacking analyses; (e) analytical testing through qualified outside laboratories; (f) cGMP compliance by company operated warehouses and fulfillment centers; (g) product recalls; (h) maintenance of retained samples; and (i) return/disposition of quarantined/discontinued product/s.
- Annual audit of fulfillment centers and bi-annual audits contract manufacturers for compliance with 21 CFR 111 and OSHA regulations.
- Weekly meetings with QC specialists to discuss any auditing that needs to be done at FC (e.g., labels, etc.) and coordinate recalls/product pulls.
- Responsible for development, implementation and maintenance of robust multi-function controlled-access product files that will include the following information for private-label: (a) full disclosure formulae (and formulae revisions); (b) product specifications; (c) raw ingredient Certificates of Analyses; (d) stability testing; (e) analytical testing; (f) labels; (g) claims; (h) claim substantiation; (i) government notification/registration files; (j) Certificates of Free Sale; (k) expiration or best before dating; and (l) vendor audit reports.
- Clear knowledge and understanding of domestic and international legislation and regulations affecting conventional food, dietary supplements and OTC drugs, with particular emphasis on the United States, Canada, the EU, and Australia.
- Implement standard requirements to ensure that vendors adhere to all applicable regulatory requirements and provide adequate claim substantiation.
- Conduct interdepartmental training and provide expert risk mitigation analysis for business unit in regard to FDA/FTC regulations for physical and digital product.
- Experience dealing with government and private agencies charged with enforcement and litigating nutrition products and the dietary supplement industry.
- Ability to analyze agency rules and official regulatory communications, applicable case law, and current events.
- Liaise and foster relationships with government agencies and trade organizations. Advise on emerging policies and legislative matters.
- Understanding of FTC regulations and continuous auditing of marketing material produced by Bodybuilding.com including email, social media, product content, advertisements, forums, and articles.
- Contract review of quality agreements, vendor agreements, and certificate of insurance (ingredient exclusion lists) and ability to assess the risk of a brand wanting to be onboarded and how this will affect these agreements.
- Annual review and maintenance of all internal compliance policies.
- Maintain product testing program for private label and 3rd party products including prop 65, qualitative, stability, and 3rd party testing (banned substance etc.).
- Oversee the customer review portal removing any unauthorized claims, escalating AERs, and maintaining the banned word list to flag reviews.
- Excellent oral and written communication skills, including experience in effectively interacting, communicating with, and presenting concise analysis of technical issues to senior management.
- Strong interpersonal, technical and analytical skills; candidate must be a strategic thinker, demonstrate organizational leadership and ability to lead by example, as well as results-oriented performance and time management skills.
- Demonstrated business orientation and focus in daily work; ability to establish instant credibility and work effectively cross departmentally to provide appropriate feedback to colleagues and management.
- Interacts with colleagues including representatives of Legal, Marketing, Sales, Business Intelligence, IT, Finance, Supply Chain, Category Management and QA/QC.
- Directs teams interaction on a cost-effective basis with outside regulatory/legal counsel, regulatory consultants, trade associations, suppliers and vendors.
- Ensure all relevant parties companywide are kept abreast of any legislative and/or regulatory changes and the impact thereof.
- A hands-on approach that encourages change and creative solutions-oriented problem- solving.
- Ability to work well in a fast-paced environment.
Education and Experience:
- A Bachelor's Degree, preferably a BS in an applicable technical field, with excellent academic credentials.
- Bio-chem background with an understanding of an ingredients chemical structure and ingredient alias/associations is a distinct advantage.
- Possible legal training.
- Minimum 5 years experience in sports supplements industry ideally within a compliance/regulatory role.
- Strong analytic, communicative, organization and implementation skills.
- Experience of working within a hands on operational role is a distinct advantage.
- Experience of working across continents and within different time zones is an advantage.
Bodybuilding.com offers its employees several benefits such as: health, dental and vision insurance; 401(k); flex time off; and employee discount.
Bodybuilding.com LLC is an Equal Opportunity Employer. The above information has been designed to indicate the general nature and level of work performed by employees in this classification. It is not designed to contain or to be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of the employee assigned to this job.
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