23 Aug
|
Ownr Search
|
Greater Toronto Area
23 Aug
Ownr Search
Greater Toronto Area
Quality Assurance Manager – Quality Systems & Co-Manufacturing
Company Overview
Our client is a fast-growing sports nutrition brand known for clean-label, fully disclosed formulations. The company works with many co-manufacturers across the USA and Canada, with that network continuing to grow.
As production scales, the company is building out a formal quality function to ensure product safety, regulatory compliance, and consistent quality across every co-manufacturing partner.
Position Summary
Our client is seeking a Quality Manager to build the company’s quality infrastructure and operating model from the ground up.
This is a foundational hire: the role owns the design and implementation of the quality management system (QMS), quality oversight of the co-manufacturing and supply chain network, the audit program, regulatory integration, and adverse event handling. The ideal candidate has hands-on experience establishing or significantly maturing a quality function in sports nutrition, dietary supplements, or food manufacturing — including direct experience qualifying and overseeing contract manufacturers — and brings perspective on what a world class QMS looks like.
Key Responsibilities
Quality Management System (QMS) Development & Implementation
- Design, implement, and maintain the company’s QMS, including SOPs, documentation and record-keeping standards, quality workflows, change control, and complaint handling.
- Own document control across the business — including a central repository of Certificates of Analysis (COAs), specifications, and all co-manufacturer compliance documentation.
Co-Manufacturer & Supply Chain Quality Oversight
- Build and lead the supplier qualification and onboarding process, including the initial audit of every new co-manufacturer before production begins.
- Provide ongoing quality oversight of all co-manufacturing partners — continually monitoring performance and compliance and flagging risks or lapses proactively rather than reactively.
- Review, verify, and track third-party certifications for each co-manufacturer, including NSF and Informed Choice, ensuring certifications remain current.
- Partner with Operations and Supply Chain to qualify new co-manufacturers and suppliers as the partner network grows.
Audit Readiness & Execution
- Develop the co-manufacturer audit program from the ground up, including audit checklists, scoring criteria, and a recurring cadence across all partners.
- Conduct in office and remote audits of co-manufacturing partners; identify findings and non-conformances, issue corrective action requests, and verify timely resolution.
- Maintain internal audit readiness so the company and its partners are prepared for regulatory inspections and third-party certification audits at any time.
Regulatory Integration
- Embed FDA requirements — including cGMP under 21 CFR Part 111 — into the QMS, supplier oversight, and day-to-day operations.
- Stay current on FDA, NSF, and Informed Choice standards relevant to sports nutrition and dietary supplement manufacturing, and translate regulatory changes into updated procedures.
Adverse Event Handling
- Establish and own the adverse event and product complaint process, including intake, documentation, investigation, escalation, and any required regulatory reporting.
- Analyze complaint and adverse event trends to drive corrective and preventive action across the co-manufacturing network.
Qualifications
- Bachelor’s degree in Food Science, Microbiology, Chemistry,
or a related field (or equivalent hands-on experience).
- 5–8+ years of quality assurance/quality management experience in sports nutrition, dietary supplement, or food manufacturing, including direct experience qualifying, auditing, and overseeing co-manufacturers or contract manufacturers.
- Demonstrated experience building or substantially maturing a QMS — SOPs, document control, change control, complaint handling — not just operating within an established one.
- Working knowledge of cGMP requirements under 21 CFR Part 111 (dietary supplements) and broader FDA regulations, with experience applying them in a co-manufacturing model.
- Familiarity with NSF and Informed Choice certification standards and processes.
- Experience with adverse event and complaint handling processes, including investigation and escalation.
- Strong document control and organizational skills; experience managing COAs and compliance records across multiple partners.
- Clear written and verbal communication skills for reporting audit findings and quality metrics to co-manufacturers and internal leadership.
- Willingness to travel to co-manufacturer facilities as needed.
What Success Looks Like
- A documented, functioning QMS — SOPs, document control, change control, and complaint handling — implemented across the business.
- A supplier qualification and onboarding process applied to every new co-manufacturer, and all 9+ partners on a recurring audit cadence with current NSF/Informed Choice certifications on file.
- A central, well-organized repository of COAs and compliance documentation covering the full co-manufacturing network.
- An operational adverse event and complaint handling process with clear escalation paths.
- Early identification and resolution of certification lapses, compliance gaps, or quality risks before they affect production or customers.
📌 Quality Assurance Manager (Greater Toronto Area)
🏢 Ownr Search
📍 Greater Toronto Area