Manager of Quality Assurance, Recall, and Regulatory Affairs (“QAP”)

Background:

Sophia’s Garden (Artisan) Inc. (SGA) has a Standard Processing license available under The Cannabis Laws. SGA is a CPG company in the business of infusing foods (a range of products ultimately) with either cannabis or hemp extracts (THC and CBD and related isolates) as a large-scale, low-cost manufacturer. The regulations provide requirements for quality-controlled, cannabis-related products, produced under secure and sanitary conditions, to Canadian markets. The future may also require GMP level standards for export markets as SGA management deems “export” to be an expansion of our business opportunities.

As a Senior Manager as well as the Leader of the QA team, the Manager of Quality Assurance, Recall, and Regulatory Affairs (“QAP”) is responsible for ensuring the Cannabis Laws are met through programs, practices, and protocols, which are executed effectively at the facility, with full responsibility for the Health Canada program including updates, inspections, mock recalls, and thorough documentation of all related records. By leading in a values-aligned fashion, the QAP plays a critical role in creating and maintaining a service-oriented team built on the foundations of Product Safety.

SGA is currently expanding our operations to increase capacity, to meet existing and future market conditions. Therefore, the QAP will also lead research into cannabinoid and food safety, improvement, and development of new products based on the science and results drawn from the research as well as community feedback, such a focus groups. The QAP will be central to the addition, expansion, and development of production lines.

SGA is not able to sponsor into Canada a person for this role; we are looking for candidates from within Canada only. All candidates must have a PhD in selected food sciences to meet the regulatory obligations of our R&D license restriction.

ROLES AND RESPONSIBILITIES:

· The QAP will ensure that the physical, chemical, and microbiological specifications of all raw materials, intermediates and finished goods comply with all regulatory and corporate quality specifications.

· The QAP will ensure the timely rejection, isolation, and disposition of all non-compliant materials and will arrange/provide analytical services as required.

· The QAP will provide technical support to the manufacturing operation by developing/maintaining the Edibles Preventative Control Plan (PCP), identifying, and assisting in the resolution of processing problems, coordinating equipment validation, expediting and facilitating corrective actions.

· The QAP ensures processing lines and facilities are following relevant food safety (PCP) and GPP programs through sanitation and preoperational inspections and assisting with GPP self-inspections and internal audits when required.

· Supervise a staff of QA Technicians and/or QA Coordinators ensuring that tasks are conducted consistently, efficiently and aligned with the needs of the business.

· Plan QA staffing requirements according to production demands.

· Build and maintain a HACCP program.

· Responsible for SOP/GPP/PCP document and training: maintenance, monitoring, and verification.

· Identify any ISO 17025 or SOP Work Requests generating from Interior Premises Audits, Sanitation Monitoring, Pre-op inspections, 3rd Party audits, or any Health Safety failures.

· Assist and accompany Health Canada inspectors during performance of their reviews or inspections and sampling as required.

· Assemble and lead annual MMPR/ISO reassessment team and conduct pre-requisite program reassessment and audit.

· Lead safety failure recall programs ensuring SOP compliance.

· Prepare and support various Audits including license recertification, internal audits, etc.

· Perform record verification as well as QA personnel competence verification.

· Responsible for the preparation of production-related batch records including THC volumes and/or masses for monthly regulatory reporting, and as required.

· Assist with analysis of data to determine root cause of deficiencies and provide feedback on performance and necessary improvements.

· Participate in cross functional SOP development and ensure that facility SOPs and related documents are controlled, in a correct format, properly stored, and distributed as per manufacturing excellence requirements, including license or regulatory reassessments, program changes, etc. as necessary.

· Lead cross functional teams completing incident investigations where product safety or product quality may be compromised.

· Advancing an attitude of continuous improvement and training of employees at hourly and salary levels.

· Take lead on execution of various initiatives to improve the quality and safety of our products.

· Support and/or lead change management activities related to processes, programs and/or systems.

· Support QA team as required (back-up for various roles, etc.).

· Other duties as required by SGA senior management.

OTHER CONSIDERATIONS:

· The successful candidate will have experience in these three key areas:

1. Food Engineering: a bachelor’s degree in food engineering as well as experience in designing new production lines, dimensioning required equipment, and developing and implementing good practices (GPP, GMP, ISO 9000, ISO 17025) as well as SOP manuals in the food industry. ​

2. Laboratory Management: experience managing multiple groups in several simultaneous projects in the laboratory (research). ​ Experience overseeing preventive maintenance, training, and operation of high-technology equipment, as well as procurement of materials and equipment for research. ​

3. Data Science and Production Coordination: management of multiple simultaneous projects, coordination of commercial production line upgrades, risk mitigation, and conflict resolution. ​ Able to identify valuable data; automate collection processes; lead continual improvement processes, in collaboration with SGA management, budgets, engineering, and design teams.

· University degree, BSc, MSc (optional), AND a PhD in Food Science or Food Engineering.

· 3 to 5 years food and/or cannabis related experience in areas of GPP and/or HACCP/PCP and/or GMP principles and programs. Proven understanding of food processes and impact on products and food safety; demonstrated ability to apply concepts through previous work.

· Must have in-depth HACCP or PCP experience including program development as well as implementation of programs and auditing of the program, specific experience in processing and quality control of food products.

· 4 years minimum experience in Laboratory Management in related sciences. Expected to lead, supervise, or support R&D projects towards new products and product improvement: Product development, and process/product improvement for products including cannabinoids.

SGA intends to complete a validated ISO 17025 GLP laboratory onsite or locally with a university to have greater access to data to support quality challenges, quality improvement, and research, as well as food development.

· Coordination: experience coordinating different disciplines and projects, including engineering and production equipment trades/providers, to ensure quality assurance and successful project completion. ​

· Problem Solving: possess strong analytical skills and have demonstrated the ability to identify and mitigate risks, resolve conflicts, and find solutions to complex design and project challenges.

· Communication: experience collaborating with various teams, including engineering, design, sales, and management teams. Effective communication is crucial in coordinating projects and ensuring smooth workflow.

· Project Management: successfully manage small to medium-sized teams and projects, ensuring they are completed on time and within budget. This includes overseeing preventive maintenance, optimizing budget utilization, and leading continual improvement processes. ​

· Documentation: experience in procuring materials and equipment, optimizing budget utilization, and ensuring compliance with health and safety regulations. This balance requires strong documentation skills.

· Pricing: knowledge and experience in pricing related to construction projects and food production, which is essential for budgeting and cost control.

· Continuous Learning: research background and ability to independently search for information and learn new concepts demonstrate commitment to continuous learning and staying current with design trends and technologies. ​

· Teamwork: a team player who excels in collaborative environments. For example, experience managing teams as well as working effectively with colleagues to achieve overall project goals.

· Attention to Detail: detail is highlighted as a strength, which is crucial in ensuring high-quality work that exceeds SGA’s customer’s expectations.

· Time Management: ability to manage multiple simultaneous projects and coordinate construction trades demonstrates strong time management skills.

· Demonstrated alignment to the SGA Leadership Values.

· Experience with automation of data and electronic Quality systems is a must.

· It is also essential to have good numerical skills and an understanding of statistics.

Considerations to be a QAP:

SGA submits QAP candidates to Health Canada and their approval is required. All candidates MUST also have security clearance, which means A) an investigation into the past 5 years of your life, and B) you must be able to pass to be considered.

The approval of proposed personnel, such as a Quality Assurance Person (QAP) or Alternate QAP, is determined based on several factors. ​ These factors include:

1. Ability to fulfill responsibilities: The proposed personnel must demonstrate their ability to fulfill the roles and responsibilities associated with the position. ​ This includes ensuring that all cannabis is approved prior to being made available for sale, approving the preventive control plan, and meeting the requirements outlined in the Cannabis Regulations. ​

2. Training, experience, and technical knowledge: The proposed personnel must possess the necessary training, experience, and technical knowledge related to the requirements of the Cannabis Regulations. ​ They should have a solid understanding of good production practices, investigations and risk mitigation, complaint management, product quality approval, testing, recall procedures, and adverse reaction reporting.

3. Qualifications and education: The proposed personnel should have relevant qualifications, such as degrees, diplomas, or certificates, supporting their formal education in areas related to the responsibilities of the position. These qualifications should be verified by providing copies of the relevant documents. ​

4. Previous approval from Health Canada: If the proposed personnel have previously been approved by Health Canada as a QAP or Alternate QAP for a cannabis license holder, it may positively influence their approval for the new position. ​ The date of prior approval and the name of the affiliated license holder should be provided. ​

5. Security clearance: The proposed personnel must hold a valid cannabis security clearance. ​ This clearance ensures that they meet the necessary security requirements to work in the cannabis industry. The expiry date and security clearance number should be provided. ​

6. Background and experience: The proposed personnel’s background and experience in the cannabis industry, including any previous roles and responsibilities, will be taken into consideration during the approval process. ​

7. Overall assessment: The approval of proposed personnel will depend on an overall assessment of their ability to conduct their responsibilities effectively and in compliance with the Cannabis Regulations. ​ This assessment considers the information provided in the application, including qualifications, experience, and training.

Job Types: Full-time, Permanent
Pay: $124,500.00-$127,000.00 per year

Schedule: Monday to Friday

Education: Doctoral Degree (required)

Work Location: In person