Market America, a product brokerage and Internet marketing company that specializes in One-to-One Marketing, is seeking an experienced Vice President of Quality Control and Regulatory Affairs for our Product Quality Control team.

ABOUT US:

Market America is a dynamic and fast-growing company specializing in e-commerce and digital marketing. We pride ourselves on innovation, customer satisfaction, and a commitment to excellence.

POSITION SUMMARY

The Vice President, Quality and Regulatory will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registration strategies for Market America products, including initial regulatory efforts and maintaining registration renewals. The position will work closely with an extended external team regarding regulatory, quality, contractors, consultants and laboratories.
This high performing professional 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 Vice President must engender credibility and confidence within and outside the company and do so as an effective communicator and collaborator.

QUALIFICATIONS:

• BS in a scientific discipline. Advanced degree preferred.
• At least 10 years of experience in dietary supplement/pharmaceutical industry
• 10+ years of experience in Regulatory strategy and Quality Control, with experience in dietary supplements preferred.
• Expert knowledge of 21 CFR Part 111 and 21 CFR Part 117.
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide development teams in building appropriate global regulatory strategy.
• 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.
  Market America offers competitive salary and generous benefits, including health, dental, vision, life, short and long-term disability insurance, a 401(k) retirement plan with company match, and an on-site health clinic.
  Qualified candidates should apply online. This position will based at our Greensboro NC offices. Sorry, we are not able to sponsor for this position.
  Market America is proud to be an equal opportunity employer.
  Market America | SHOP.COM is changing the way people shop and changing the economic paradigm so anyone can become financially independent by creating their own economy and converting their spending into earning with the Shopping Annuity®.

• Leads regulatory activities for all assets to ensure alignment and compliance with local and regional GMP requirements and registration requirements as well as with company policies.
• Accountable for development and implementation of effective regulatory strategies across products and product life cycles
• Ensures stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Anticipates and manages risks.
• Monitors and anticipates trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
• Hires, leads and coaches Quality Control, Product Information, Regulatory, Science, and production teams to create harmonized cross-functionality.
• Partners with the Legal Department and external partners to ensure that all regulatory submissions, archives, and requirements are well executed.
• 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.
• Develops and implements standards, policies, and procedures for GMP, doing so in a way that engenders support and full participation of stakeholders.
• Oversees vendors supporting quality and compliance.