Senior Manager, Quality & Regulatory Affairs

About Us

Have you ever wondered why we rely on harmful chemicals and artificial ingredients to maintain our body's health? We have. After years of battling on-and-off tonsillitis, our founder Carly Stein finally found relief in an ingredient called propolis: a combination of tree and plant resin created by bees to protect the hive. We aren't just creating cleaner alternatives to the traditional medicine cabinet; we're creating all-around cleaner products. Period. We merge modern science with natural medicine to prove that clean medicine can actually work. We believe that today's most common health problems can be solved with better-for-you ingredients found right in nature. We source the highest-quality, humane ingredients, and we never water them down with artificial extras. We care about the world around us and the people in it. It's what drives our entire brand.

About the Role

Beekeeper's Naturals is looking for an experienced quality and regulatory professional to lead our quality programs and serve as our day-to-day quality and regulatory lead. This is a critical role for a fast-growing premium supplement brand, ensuring every product that carries our name meets our quality standards and regulatory obligations.

Reporting to the COO, you will manage our contract manufacturing and supplier partner quality programs, lead US and Canadian regulatory compliance, and manage a QA Manager who handles daily quality operations. You'll work closely with Innovation, Operations, Sales, and Legal, and partner with the COO on quality strategy and escalated decisions.

Key Duties & Responsibilities

Contract Partner Performance & Oversight

• 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 when partners fall short.
• Develop and maintain quality agreements with CMOs and key suppliers, ensuring responsibilities, testing requirements, and deviation notification expectations are clearly defined and followed.
• Lead the CMO qualification and audit program — initial qualification, periodic audits, and performance scorecarding. Escalate significant performance concerns and recommend remediation or disqualification to the COO where warranted.
• 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 — lab qualification, method oversight, and ongoing performance monitoring.

Raw Materials, Specifications & Testing

• Develop and maintain raw material, component, and finished product specifications in alignment with BKN's quality standards, ensuring specifications are enforced across the supply base.
• 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, including scope, methods, and acceptance criteria, in coordination with the COO.
• 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.

Regulatory Affairs

• Serve as the company's regulatory lead for US (FDA / DSHEA, 21 CFR Part 111) and Canadian (Health Canada, NHP Regulations) compliance, coordinating with the COO and external counsel on significant matters.
• Manage adverse event reporting and coordination with regulatory counsel.
• Lead label and claims review — regulatory review and approval of label copy, structure/function claims, and marketing claims in coordination with the COO.
• 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 to the COO and cross-functional team.

Team & Cross-functional Leadership

• 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.

Job 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.

Location, Compensation & Benefits

• Full-time, permanent position.
• Fully remote. Will consider applicants based in Ontario, Canada or the US.
• Periodic travel to supply partners required.
• Reports to the COO. Manages QA Manager.
• Health benefits provided from Day 1.
• Unlimited Time Off.
• Participation in the company's employee options program.