Senior Manager, Quality & Regulatory Affairs

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.

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 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.
• 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.
• 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.