Senior Manager, Quality & Regulatory Affairs

Beekeeper's Naturals, Inc.

3d•Remote

About The Position

Beekeeper's Naturals is seeking an experienced quality and regulatory professional to lead its quality programs and serve as the day-to-day quality and regulatory lead. This is a critical role for a fast-growing premium supplement brand, ensuring every product that carries the Beekeeper's Naturals name meets quality standards and regulatory obligations. The role involves managing contract manufacturing and supplier partner quality programs, leading US and Canadian regulatory compliance, and managing a QA Manager. The position will collaborate closely with Innovation, Operations, Sales, and Legal, and partner with the COO on quality strategy and escalated decisions.

Requirements

8+ years in quality assurance and/or regulatory affairs in dietary supplements or natural health products.
Solid working knowledge of 21 CFR Part 111, DSHEA, and Health Canada NHP Regulations.
Experience managing contract manufacturer quality in a brand-owner model — building accountability into supplier relationships through audits, quality agreements, and performance management.
Experience conducting CMO facility audits and driving corrective action.
Familiarity with FDA and Health Canada requirements and processes; direct regulatory interface experience a plus.
Experience supporting adverse event reporting obligations.
Prior people management experience required.
Bachelor's degree in relevant field (food science, chemistry, biology, or related).
Strong organizational and communication skills; comfortable working cross-functionally in a lean, remote environment.

Responsibilities

Manage day-to-day performance of contract manufacturing and supplier partners, setting clear Quality expectations, tracking execution against BKN's standards, identifying gaps, and driving corrective action.
Develop and maintain quality agreements with CMOs and key suppliers.
Lead the CMO qualification and audit program, including initial qualification, periodic audits, and performance scorecarding.
Serve as the primary point of contact for CMO deviations, OOS results, and quality events, leading root cause investigation, reviewing corrective actions, and coordinating lot disposition decisions.
Manage the third-party lab program, including lab qualification, method oversight, and ongoing performance monitoring.
Develop and maintain raw material, component, and finished product specifications in alignment with BKN's quality standards.
Lead the vendor qualification program, defining approval criteria, testing requirements, and ongoing performance standards for ingredient and packaging suppliers.
Define and manage incoming material and finished product testing requirements.
Oversee the stability testing program and ensure data supports label claims throughout shelf life.
Manage third-party certification programs and ensure requirements are reflected in CMO quality agreements.
Serve as the company's regulatory lead for US (FDA / DSHEA, 21 CFR Part 111) and Canadian (Health Canada, NHP Regulations) compliance.
Manage adverse event reporting and coordination with regulatory counsel.
Lead label and claims review, including regulatory review and approval of label copy, structure/function claims, and marketing claims.
Manage Canadian importation requirements: site license maintenance, PLA submissions, and NHP product file management.
Monitor the US and Canadian regulatory landscape and communicate relevant updates and impact.
Manage and develop the QA Manager, providing clear direction and day-to-day support.
Partner with Innovation on quality and regulatory requirements for new product development.
Provide regular reporting to the COO on quality program status, partner performance, and regulatory matters.