Senior Manager, Quality & Regulatory Affairs

Accountabilities:

- Lead day-to-day quality and performance management for contract manufacturers and key suppliers, establishing expectations, monitoring execution, identifying gaps, and driving corrective actions.

- Develop and maintain quality agreements with contract manufacturing organizations and strategic suppliers, clearly defining responsibilities, testing requirements, and deviation notification processes.

- Lead contract manufacturer qualification and audit programs, including initial qualification, periodic audits, performance scorecards, remediation plans, and escalation of significant concerns.

- Serve as the primary quality contact for manufacturing deviations, out-of-specification results, and other quality events, coordinating root cause investigations, corrective actions, and lot disposition decisions.

- Manage the third-party laboratory program, including laboratory qualification, testing method oversight, and ongoing performance monitoring.

- Develop and maintain specifications for raw materials, components, and finished products while ensuring quality standards are consistently applied across the supply base.

- Lead supplier qualification programs by defining approval criteria, testing requirements, and ongoing performance expectations for ingredient and packaging suppliers.

- Define and oversee incoming material and finished product testing requirements, including testing scope, methods, and acceptance criteria.

- Manage stability testing programs and ensure supporting data is sufficient to substantiate product claims throughout shelf life.

- Oversee third-party certification programs and ensure relevant requirements are incorporated into quality agreements and supplier processes.

- Serve as the regulatory lead for US and Canadian compliance, including FDA, DSHEA, 21 CFR Part 111, Health Canada, and Natural Health Product regulations.

- Coordinate significant regulatory matters with executive leadership and external regulatory counsel.

- Manage adverse event reporting activities and coordinate related regulatory requirements.

- Lead regulatory review and approval of product labels, structure/function claims, marketing claims, and other consumer-facing product communications.

- Manage Canadian importation and regulatory requirements, including site license maintenance, product license applications, and natural health product files.

- Monitor developments in US and Canadian regulations and communicate relevant changes, risks, and business implications to leadership and cross-functional stakeholders.

- Manage and develop the QA Manager, providing direction, coaching, and support across day-to-day quality operations.

- Partner with Innovation on quality and regulatory requirements throughout new product development.

- Provide regular reporting to the COO on quality program performance, supplier and manufacturing partner performance, regulatory matters, risks, and key decisions.

Requirements:

- 8+ years of experience in quality assurance and/or regulatory affairs within dietary supplements, natural health products, or a closely related industry.

- Strong working knowledge of FDA requirements, including 21 CFR Part 111 and DSHEA, as well as Health Canada Natural Health Product regulations.

- Demonstrated experience managing contract manufacturer quality within a brand-owner environment, including supplier accountability, quality agreements, audits, and performance management.

- Hands-on experience conducting contract manufacturing facility audits and driving corrective and preventive actions.

- Familiarity with FDA and Health Canada regulatory requirements and processes; direct experience interacting with regulatory authorities is a plus.

- Experience supporting adverse event reporting and related regulatory obligations.

- Previous people management experience with the ability to provide clear direction, coaching, and accountability.

- Bachelor's degree in food science, chemistry, biology, or another relevant scientific discipline.

- Strong organizational skills and attention to detail, with the ability to manage multiple quality and regulatory priorities simultaneously.

- Excellent written and verbal communication skills and confidence working with executive, technical, operational, and external stakeholders.

- Comfortable operating independently and collaboratively in a lean, remote, and fast-paced environment.

- Willingness to travel periodically to manufacturing and supply partners as required.

Benefits:

- Full-time, permanent position.

- Fully remote work, with applicants considered across the United States and Ontario, Canada.

- Health benefits provided from Day 1.

- Unlimited time off.

- Participation in the employee options program.

- Opportunity to lead quality and regulatory strategy across US and Canadian markets.

- Direct collaboration with executive leadership and cross-functional teams.

- Periodic travel to supply partners.

How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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