VP of Quality Control - Regulatory Affairs
- Greensboro, NC
- Permanent
- Full-time
- 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.
- 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.