The Opportunity Carbon Extracts is seeking an experienced Head of Quality to lead and strengthen our Quality function as we scale cannabis extraction and manufacturing operations and expand our support of international medicinal cannabis markets. This is a senior leadership position responsible for quality strategy, people leadership, operational quality oversight, validation, regulatory compliance, and the continued development of robust and scalable quality systems. The Head of Quality will lead the entire Quality function, including the Quality Assurance Person (QAP), Quality Assurance, Quality Control, and associated quality personnel and service providers. The role will work closely with Operations, Production, Engineering, Regulatory Affairs, and executive leadership. We are looking for someone with strong pharmaceutical GMP experience who can lead a team while remaining directly involved in the work. This includes technical writing, investigations, CAPA, qualification and validation, inspection readiness, and the development and improvement of quality systems. This is not solely an administrative or oversight role. The successful candidate must be comfortable working directly with technical documentation, manufacturing processes, Quality personnel, and operational teams.

Key Responsibilities
Quality Leadership and Team Development
- Lead the entire Quality function and establish clear responsibilities, priorities, performance expectations, and development plans.
- Supervise and support the QAP while preserving the QAP's designated regulatory responsibilities and independent decision-making authority.
- Recruit, coach, train, and develop Quality personnel as the organization grows.
- Establish appropriate approval and delegation frameworks based on qualifications, training, and regulatory requirements.
- Develop the Quality strategy, staffing requirements, priorities, and annual objectives in alignment with operational and commercial growth.
- Promote a culture of product quality, patient safety, data integrity, accountability, and continuous improvement.
- Exercise independent quality judgment, including the authority to place materials or products on hold, stop activities that may compromise quality, and escalate significant risks to executive leadership. Quality Management Systems
- Own and continuously improve the Quality Management System to support compliant, consistent, and scalable operations.
- Oversee deviations, investigations, CAPA, change control, complaints, recalls, document control, training, and quality risk management.
- Ensure investigations establish scientifically supported root causes and that corrective actions are timely, effective, and sustained.
- Lead management reviews and establish meaningful quality metrics and trending.
- Maintain accurate, complete, traceable, and readily retrievable quality records across paper and electronic systems.
- Oversee product quality reviews, trend analysis, and continuous improvement initiatives. Technical Writing and Documentation
- Personally author and oversee the development of GMP and quality documentation, including SOPs, work instructions, policies, specifications, protocols, reports, risk assessments, investigations, CAPA, validation documents, master manufacturing documents, and quality agreements.
- Translate regulatory requirements, technical processes, and operational practices into clear, accurate, and executable controlled documents.
- Ensure technical documentation is scientifically sound, appropriately detailed, internally consistent, and suitable for regulatory inspection and third-party audit.
- Work directly with Operations, Production, Engineering, Regulatory Affairs, and subject matter experts to accurately document manufacturing processes, controls, and quality requirements.
- Establish strong documentation standards and develop the technical writing capabilities of Quality personnel.
- Lead the preparation and technical writing of responses to regulatory inspections, audit observations, deficiencies, quality inquiries, and other regulatory or partner requests.
- Ensure regulatory and audit commitments are scientifically justified, achievable, appropriately documented, and completed as committed. Qualification, Validation and Scale-Up
- Own the site's validation strategy and Validation Master Plan.
- Personally draft, review, and approve risk assessments, qualification and validation protocols, acceptance criteria, execution records, and final reports.
- Lead Quality oversight of equipment, facilities, utilities, processes, cleaning, analytical methods,



and computerized system qualification and validation, as applicable.
- Lead process validation activities for extraction, purification, formulation, and other applicable manufacturing processes as operations scale.
- Work with technical and operational teams to establish critical quality attributes, critical process parameters, operating ranges, sampling plans, and scientifically justified acceptance criteria.
- Ensure validation deviations are appropriately investigated and resolved and conclusions are supported by complete and reliable data.
- Establish continued process verification, ongoing monitoring, and appropriate requalification and revalidation requirements.
- Assess the quality impact of changes to equipment, batch sizes, suppliers, materials, facilities, software, and manufacturing processes.
- Provide Quality leadership for technology transfer, new product introduction, scale-up, and commercial readiness.
- Oversee computerized system validation, including requirements, access controls, audit trails, data integrity, change management, and lifecycle maintenance. Manufacturing and Product Quality
- Provide Quality oversight of production, packaging, labelling, storage, testing, and distribution activities.
- Ensure materials, intermediates, bulk extracts, and finished products meet approved specifications and applicable market requirements.
- Oversee batch documentation review and product disposition processes and ensure release decisions are made by appropriately authorized personnel.
- Support the QAP in fulfilling applicable regulatory responsibilities relating to product quality, investigations, and release.
- Oversee analytical methods, sampling plans, laboratory controls, stability programs, and investigations of out-of-specification and out-of-trend results.
- Ensure appropriate controls are maintained for potency, consistency, residual solvents, pesticides, microbial contamination, and other relevant impurities.
- Oversee sanitation, cleaning, environmental monitoring, contamination prevention, and cross-contamination controls.
- Ensure storage conditions, shelf-life assignments, packaging suitability, and transportation controls are supported by appropriate evidence. Regulatory Compliance and Inspection Readiness
- Maintain ongoing inspection readiness and serve as a senior Quality representative during Health Canada inspections, customer audits, and third-party assessments.
- Ensure operations meet applicable Canadian cannabis requirements and pharmaceutical GMP requirements relevant to the company's licensed activities, products, and markets.
- Maintain and advance readiness for applicable EU GMP and international medicinal cannabis requirements.
- Lead responses to inspection and audit findings, including remediation plans, commitments, supporting evidence, and effectiveness verification.
- Maintain oversight of existing audit and regulatory commitments and ensure actions are completed and sustained.
- Conduct internal audits and gap assessments to identify compliance risks before they affect product quality or market access.
- Translate regulatory changes and inspection findings into practical procedures, controls, training, and operational improvements. Supplier and External Partner Quality
- Establish and maintain risk-based qualification, approval, monitoring, and requalification programs for suppliers and service providers.
- Oversee the quality of incoming cannabis materials, ingredients, solvents, packaging components, and other critical supplies.
- Lead or coordinate supplier audits and qualification of contract laboratories, manufacturers, warehouses, and other critical partners.
- Develop and maintain quality agreements defining responsibilities for testing, release, changes, deviations, complaints, recalls, and record retention.
- Monitor supplier quality performance and ensure issues and changes are appropriately investigated and resolved. International Medicinal Cannabis
- Lead Quality readiness for international medicinal cannabis supply in collaboration with Regulatory Affairs, commercial teams, logistics providers, and importing partners.




- Ensure destination-specific quality requirements are incorporated into specifications, testing programs, manufacturing controls, documentation, and quality agreements.
- Oversee export quality packages, including certificates of analysis, batch documentation, stability information, and supporting quality records.
- Support importing partners and Qualified Persons with documentation and technical responses required for applicable certification and batch release processes.
- Establish clear quality responsibilities across the international supply chain for product disposition, traceability, transportation conditions, excursions, complaints, and recalls.
- Identify quality gaps associated with proposed markets and lead remediation before commercial supply begins. Required Qualifications and Experience
- Bachelor's degree in pharmacy, chemistry, biochemistry, microbiology, pharmaceutical sciences, engineering, or a related scientific discipline.
- Minimum three years of experience in a supervisory or management role within a GMP-regulated pharmaceutical manufacturing environment, with direct responsibility for Quality Assurance, Quality Control, or Quality Systems.
- Demonstrated experience managing and developing Quality personnel.
- Strong working knowledge of pharmaceutical GMP and the ability to apply GMP principles practically within manufacturing operations.
- Working knowledge of Health Canada GMP expectations and Canadian cannabis requirements, including the responsibilities and authority of the QAP.
- Practical knowledge of EU GMP and quality requirements supporting international medicinal cannabis supply.
- Demonstrated ownership of qualification and validation programs, including direct experience authoring protocols and reports.
- Strong technical writing skills with demonstrated ability to independently produce clear, executable SOPs, protocols, risk assessments, investigations, CAPA, technical reports, and regulatory responses.
- Experience supporting manufacturing scale-up, process changes, technology transfer, or recent product introduction.
- Proven ability to lead investigations, establish effective CAPA, and make defensible, science-based quality decisions.
- Experience hosting regulatory inspections or significant customer audits and managing responses and remediation commitments.
- Experience with supplier qualification, contract laboratory oversight, and quality agreements.
- Strong understanding of data integrity and computerized system validation. Pharmaceutical supervisory or management experience is essential. Cannabis industry experience is valuable but does not replace this requirement. Preferred Qualifications
- Experience with medicinal cannabis, botanical extracts, active pharmaceutical ingredients (APIs), or other complex extracted products.
- Experience supporting EU GMP inspections, international medicinal cannabis exports, and interactions with importing partners or Qualified Persons.
- Practical experience with extraction, purification, distillation, formulation, or related process technologies.
- Experience building or strengthening a Quality function during manufacturing expansion.
- Experience implementing or improving electronic Quality Management Systems.
- Advanced degree or relevant professional Quality certification. Who We're Looking For We are looking for someone who combines strong scientific and regulatory knowledge with practical operational judgment. The successful candidate must be comfortable leading people while also remaining hands-on when required. You should be equally comfortable working on the manufacturing floor, challenging inadequate controls, writing a validation protocol or investigation, preparing for an inspection, developing members of your team, and presenting quality risks and priorities to senior leadership. This role requires someone who can establish high standards without creating unnecessary bureaucracy and who understands that an effective Quality function must protect product quality and regulatory compliance while supporting reliable manufacturing and sustainable growth Pay: $80,000.00-$110,000.00 per year

Experience:
- GMP: 3 years (required)
- Quality assurance: 3 years (required)
- Quality management: 3 years (required)
- Management: 3 years (required)
- Pharma/GMP Quality: 3 years (required)
- Technical writing: 3 years (required)
- Validation/Qualification: 3 years (required)
- Pharmaceutical Manufacturing: 3 years (required)
- CAPA / investigations: 1 year (preferred)
- EU GMP : 1 year (required)
- Cannabis Knowledge: 1 year (preferred) Work

Location:
In person

📌 Head of Quality (Etobicoke)
🏢 Carbon Extracts
📍 Etobicoke