Quality and Compliance Specialist - North America

WedderspoonMalvern, PA
Onsite

About The Position

Wedderspoon Organic is seeking a part-time (20 hours per week) regulatory and quality expert to join their Malvern office. This role is crucial for ensuring all products meet the highest standards of safety, quality, and legality by acting as the authoritative voice on FDA, Health Canada, and FSMA requirements for their contract manufacturer (CMO) network. The specialist will report to the Chief Operating Officer and collaborate closely with the Senior Operations and Compliance Manager in New Zealand. The company, a pioneer in Mānuka honey in the U.S., is expanding its product line and brand presence, recently joining Florenz, a collective of New Zealand health and wellness brands.

Requirements

  • 3+ years in quality assurance or compliance within food, dietary supplement, or natural products industries.
  • Direct, hands-on experience in FDA-regulated environments - 21 CFR Part 111, FSMA, facility registration, import/export.
  • Proven track record managing supplier qualification programs and quality management systems.
  • Strong communicator with excellent attention to detail.

Nice To Haves

  • Experience with Health Canada NHP regulations and/or other international markets is desirable.

Responsibilities

  • Ensure every product meets the highest standards of safety, quality, and legality by managing FDA, Health Canada, and FSMA requirements for the contract manufacturer (CMO) network.
  • Oversee Regulatory Compliance including FDA 21 CFR Part 111 cGMP's, FSMA Preventative Controls, Health Canada NHP regulations, labelling and organic claims.
  • Manage CMO Quality, including supplier qualification, quality agreements, audits, deviations, investigations, change control, and product release.
  • Lead internal and external audits, manage regulatory inspections, and drive corrective and preventative action programs (CAPA).
  • Partner with R&D, Operations, NPD, Regulatory, and Marketing teams to ensure quality is embedded across the business.
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