Overview
Crate 61 Organics is a Toronto‑based, vertically integrated cold‑process soap manufacturer entering a pivotal stage of operational maturity. As the company expands its footprint in clean personal care, we are building a world‑class quality and regulatory foundation aligned with ISO 22716, ISO 9001, and FDA cosmetic GMP expectations.
To support this growth, Crate 61 is seeking an experienced Quality Assurance & Regulatory Affairs Manager to lead the implementation, and continuous improvement of a robust, scalable quality and regulatory management system. This role will serve as the primary owner of all quality and compliance programs - driving disciplined execution on the production floor, enforcing standards, strengthening supplier and material controls, and embedding a culture of proactive quality across the organization.
The successful candidate will assist the company through its cosmetic GMP transition and remain accountable for maintaining, improving, and evolving the system long‑term as Crate 61 continues to scale.
Responsibilities
The Quality Assurance & Regulatory Affairs Manager will oversee Crate 61’s quality and regulatory programs, guiding manufacturing operations through the transition to a fully compliant cosmetic GMP environment. The role ensures robust controls for raw materials, finished products, suppliers, documentation, and regulatory submissions while embedding quality discipline across the production lifecycle.
· Establishing lot-coding, labelling, and material status systems (release/quarantine/reject).
· Work with QC to assess the risk associated with the microbiological testing risks for waterless finished products (bar soap), and determine which testing activities should be outsourced versus performed in-house.
· Assist QC in developing basic in-house physical and chemical testing capabilities (e.g., pH testing protocols, calibration procedures), and support the qualification of external laboratories for stability and other required testing.
· Ensure compliance and recordkeeping for all mandated quality checks, testing, sampling, and sanitation activities.
· Preparation for, participation in, and support resolution activities for internal, customer, and certification audits.
· Track, analyze, and lead initiatives related to quality issues and customer complaint matters.
· Serve as the primary plant liaison with Customer Service / Consumer Affairs and interface with consumers regarding quality and complaint matters.
· Lead quality and innovation initiatives, including maintaining and improving the Crate 61 Quality Management System and Cosmetic GMP Program.
· Oversee permitting and licensing requirements for the facility. · Manage budgeting, purchasing, and inventory of quality-related supplies (filters, chemicals, lab materials).
· Administer the Crate 61 Quality and Cosmetics GMP Management System and ensure compliance with all regulatory and company requirements.
· May have opportunities to serve as plant representative for quality audits (internal, customer and certification) and initiatives. · Coordinate activities and maintain strong relationships with key vendors.
· Support performance management and development of QA & QC team members.
· Drive improvements in plant performance against KPIs, including quality objectives and regulatory compliance.
· Provide day-to-day leadership to departments.
· Act as the primary liaison to the corporate team, external laboratories, and regulatory agencies (when needed).
· Conduct batch record reviews and make product release or rejection decisions.
· Manage regulatory filings and correspondence with FDA (including MoCRA registration and reporting) and Health Canada (Cosmetic Notification).
· Oversee complaint, adverse event, and recall processes.
· Direct supplier and raw material qualification activities.
· Train staff on GMP practices and maintain training documentation.
Qualifications
- Strong foundation in Regulatory Compliance and Regulatory Requirements relevant to cosmetics, personal care, or consumer packaged goods.
- 5+ years of experience in quality assurance and/or regulatory affairs within cosmetics, personal care, or related regulated manufacturing (pharma/food GMP experience considered).
- Working knowledge of FDA cosmetic regulations (including MoCRA) and Health Canada Cosmetic Notification requirementsDemonstrated technical writing skills (e.g. SOP, work instructions, validation protocols, reports)
- Experience in Regulatory Affairs, including preparing, reviewing, and maintaining regulatory documentation and supporting product registrations or notifications.
- Demonstrated Analytical Skills to interpret data, assess risks, and support decision-making related to quality and compliance.
- Basic understanding of Finance to evaluate the cost and impact of regulatory and quality initiatives on the business.
- Microbiology laboratory management experience.
- Previous experience in quality assurance or regulatory management within manufacturing or FMCG environments.
- Experience with cold-process soap or waterless/anhydrous cosmetic products (asset; but not required).
- Excellent written and verbal communication skills, with the ability to translate complex regulations into clear guidance.
- Self-directed, proactive, and demonstrates maturity appropriate for an effective manager.
- Professional certifications in quality or regulatory disciplines (e.g., QA, RA) are considered an advantage.
