Director of Quality Assurance and Regulatory Affairs

Corporate Mission:

Market America’s mission is to provide a system for entrepreneurs to create supplemental income, while providing consumers worldwide with a better way to shop. Through revolutionary technology and the power of people, we are creating the economy of the future.

Position Summary:

The Director of Quality & Regulatory will work collaboratively with colleagues across the company, and with outside partners, to design and execute global strategies for Market America products, including regulatory and compliance efforts and maintenance. The position will work closely with an extended external team regarding regulatory, quality, contractors, consultants, certifiers and laboratories.

The high performing professional who fills this position must have a blend of strategic insight, functional expertise, leadership, people management and hands-on execution. The role requires someone who can immediately apply quality systems and regulatory compliance frameworks flexibly within an innovative environment. The Director must engender credibility and confidence within and outside the company and do so as an effective communicator and collaborator.

Essential Function and Responsibilities:

• Leads regulatory and compliance activities for all assets to ensure alignment and compliance with local and regional GxP, permits, licenses and registration requirements as well as with company policies.
• Manage and implementation of effective regulatory and quality strategies across products and product life cycles.
• Ensure stakeholders are apprised of developments that may impact regulatory and GxP success, exercising sound judgement and communicating in a professional and timely manner. Anticipates and manages risks.
• Monitors and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
• leads and coaches Quality, Product Information, Regulatory, Science, and production teams to create harmonized cross-functionality.
• Collaborates with Warehouse, Inventory Control, Shipping, and Purchasing to provide proper Customs documentation for outbound shipments to foreign markets.
• Accountable for comprehensive quality management strategy to ensure compliance with regulatory requirements, including FDA, Australia TGA, Health Canada, Malaysia NPRA, Taiwan FDA, and Indonesia BPOM.
• Interprets regulations, determines quality requirements, and works closely with internal cross-functional teams and external partners to execute quality strategy to support overall product quality.
• Help Develop and implement standards, policies, and procedures for GxP, doing so in a way that engenders support and full participation of stakeholders.
• Manages audits, certifications, and vendors support for quality and compliance.

Supervisory Responsibilities:

• May direct the work of other employees

Perform any other functions and duties assigned and necessary for the smooth and efficient operation of Market America.

Education & Experience:

• BS in a scientific discipline. Advanced degree preferred.
• At least 3 years of experience in dietary supplements, pharmaceutical industries, with cosmetics industry a plus.
• 5+ years of experience in Regulatory strategy and Quality Assurance, with experience in dietary supplements preferred.
• Expert knowledge of 21 CR Part 111, 117 and the 700 series.
• Understands and interprets scientific data as it relates to regulatory requirements.
• Able to handle multiple assignments in a fast-paced environment with changing priorities.
• Strong oral and written communications skills as well as presentation skills to leadership and peers at all levels.

Computer/Communication Skills:

• Proficient use of MS Office programs: Word, Excel, and Outlook, required

• High energy level, comfortable performing multifaceted strategic projects in conjunction with day-to-day tactical activities
• Ability to get along and work with diverse personalities; tactful, mature, flexible
• Prioritizes and models good communication skills; follows up, timely responses, proactive and positive in approach
• Above moderate to high levels in reading comprehension, writing, and speaking in English; active listening; attention to detail; critical thinking; mathematics, creative problem solving; complex problem solving; and judgment.
• Participative management style—advocate of team concept
• Results and people oriented, with judgment to balance other business considerations
• Service oriented, but assertive/persuasive

Travel:

• Remote work with business approval
• Annual conference participation and related travel

Physical Requirements and Work Environment:

• Normal office environment with little exposure to dust and weather conditions prevalent at the time (i.e., cold hot/humid)
• Routinely uses standard office equipment such as computers, phones, cameras, photocopiers, and filing cabinets
• Regularly required to talk, walk, stand, bend, twist, reach with hands and arms, stoop kneel and crouch
• Raise and lower an object from one level to the another, less than twenty (20) pounds.
• Visual acuity must be a minimum or 20/40 (corrected) and normal hand/eye coordination
• Normal or corrected hearing
• Must be able to perform in an office environment where ninety (90) percent of work is performed sitting.
• Occasional long or irregular hours of work

Equal Opportunity/Affirmative Action Employer. Market America | SHOP.COM considers candidates regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, disability or veteran status, or any other characteristic protected by law.