Exciting opportunity with an established company! Our client is looking for a Director of Quality and Regulatory Affairs for their growing organization. A midsized group currently at $40-million annually and growing! Our client is looking for someone with innovative ideas and expertise in Over-The-Counter (OTC) and Dietary Supplementation manufacturing.
This role is located in Woodbine, Iowa, 45 minutes outside of Omaha, Nebraska. Corporate office is located in Iowa, they also have a site in Atlanta, Georgia.
Director of Quality and Regulatory Affairs
Reporting directly to the VP of Quality, this role will develop, refine, implement and maintain quality management systems, regulatory strategies, and compliance initiatives. Lead teams with innovative ideas around quality assurance (QA), quality management systems (QMS), good manufacturing practices (GMP), and good documentation practices (GDocP). Improve current procedures for quality testing, including raw material testing, in-process testing, and finished product testing alongside the QC team. Be the point of contact (POC) for regulatory agencies (FDA, FTC) stay up to date on industry changes and best practices. Lead and teach current teams best standards and practices, mentor, train and create a team that enjoys collaboration.
Qualifications:
- Bachelor's degree in a relevant scientific discipline (e.g., Chemistry, Pharmacy, Biology), advanced degree preferred.
- Minimum of 10 years of progressive experience in quality assurance, regulatory affairs, or a related field within the pharmaceutical, over the counter (OTC), or dietary supplement industry.In-depth knowledge of FDA regulations, including 21 CFR Part 111 (Dietary Supplements) and 21 CFR Part 210, 211 (Pharmaceuticals), as well as relevant industry standards (e.g., USP, NSF, NPA).
- Experience with quality management systems (e.g., ISO 9001, ISO 13485) and regulatory submissions (e.g., NDAs, DMFs, GRAS notifications).
- Strong leadership and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
- Excellent written and verbal communication skills, with the ability to convey complex regulatory requirements and concepts in a clear and concise manner.
- Detail-oriented with strong analytical and problem-solving abilities.
- Experience managing and developing a team of quality and regulatory professionals.
- Certification in quality or regulatory affairs (e.g., RAPS, ASQ) is a plus.
- This job description is intended to convey information essential to understanding the scope of the position and is not exhaustive. Duties may be modified over time as the company's needs evolve.
