Director – Quality Assurance and Regulatory Compliance
Custom Cannabis is a Canadian medical and lifestyle cannabis producer growing cannabis under the Access to Cannabis for Medical Purposes Regulations (ACMPR) in Claresholm, Alberta. Our purpose-built greenhouses are designed to take advantage of nature’s elements for natural cannabis production. The result is high quality medical cannabis for the empowerment of patients on their journey toward wellness.
The Director of QA and Regulatory Compliance will ensure that the product produced by Custom Cannabis meets the company’s high quality and consistency objectives. This position will be responsible for adherence to SOP’s as well as, the development of SOP’s for expansion projects. He/she must have the ability to meet both external and internal compliance and regulatory requirements including legal compliance and customer expectations. The position is accountable for development, implementation and ongoing monitoring of the quality assurance program and control systems in compliance with the Cannabis Act.
- Working experience as a Quality Assurance Manager in a GMP, HACCP, GAP regulated environment with strong proficiency in documentation and analytical testing.
- Good Understanding of The Cannabis Act, Controlled Drugs and Substances Act, Pest Control Products Act, Fertilizer Act, HACCP, OH & S.
- Strong leadership qualities, ability to liaise with internal & external stake holders.
Scope of Responsibility/Primary Objectives:
- Report to the Vice President of Operations (VPO) and Chief Operating Officer (COO).
- Full-time position, based in Town of Claresholm, Alberta
- Ensure that all processing activities are carried out in accordance with the Standard Operating Procedures (SOP), to result in consistent highest quality cannabis products.
- Collaborate with finance, accounting, CRA, Health Canada and wholesale customers on monthly reports in a timely manner.
- Collaborate with other relevant departments including Production and Operations to ensure compliance with Health Canada regulations and guidelines, adhering to the Cannabis Act.
- Must ensure that all technical documents at site in use are current. All the master documents such as site policy documents and Standard Operating Procedures (SOP) must be controlled and secured in accordance with Good Documentation Practices.
- Responsible for managing and coordinating QA staff, creating department efficiencies, and providing leadership support.
- Must be able to communicate effectively to all levels of the organization and assist in training of employees.
- Implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.
- Responsible for planning, implementing, and managing compliance of manufacturing and production process with internal and external safety, quality and regulatory standards/requirements for worldwide distributions.
- Assures compliance to in-house and/or external specifications and standards, such as GMP, GGP, GPP, GDP, Cannabis Act.
- Design methods and procedures for inspecting testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
- Perform internal audits, and vendor evaluation audits on regular basis to determine quality qualifications.
- Actively participate in external audits conducted such as Health Canada Inspections, OH & S inspections.
- Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- Assist product support areas in gathering and analyzing data.
- Participate in the reviewing of engineering designs to contribute quality requirements and considerations.
- Assistance with Inventory & stock handling / shipping / receiving and organization to SOP’s.
- Maintain regular collaborative communication with Director of Production & Lead Growers.
- Understand, and follow all SOPs and related forms to GMP standards.
- Complete all required documentation using good documentation practices.
- Attend and participate in production and management meetings (as required).
- Other related support duties as assigned to maintain efficient business operations.
Education, Experience, Qualifications and Skills
- in Biological Sciences/ Pharmacy/ Food (preferred)
- Previous/existing Health Canada Security Clearance and QAP approval from Health Canada and work experience with a Canadian Licensed Producer (LP) is a significant asset.
- 5 years (min.) experience in Quality Assurance/Quality Control as a supervisor, manager position.
- Previous experience with inspecting methods in the design and production of cannabis an asset.
- Project planning and management capabilities, experience with change management.
- Previous experience as stand-alone QA/QC resource; direct responsibility for determining the strategy to meet quality objectives with the available resources as well as tactical execution.
- Strong team player with the ability to conduct work with confidentiality and professionalism.
- Ability to prioritize and organize a changing workload while maintaining a high level of integrity and accuracy. Ability to work under pressure and to scheduled deadlines.
- Self-starter with the ability to identify problems and then develop and implement solutions.
- Strong analytical skills and problem-solving skills.
- Ability to develop reporting in an efficient and effective manner.
- Ability to multi-task in a rapidly changing environment.
- Experience in using cannabis tracking technology; including Ample Organics, CTLS Reporting system.
- Proficiency in Office 365, particularly Word, Excel, Power Point, Teams, etc.
- Accountable for QA department results, strives to meet and exceed expectations.
- Strong written, verbal and communication skills.
- Be positive, energetic and comfortable in an open, dynamic and collaborative company culture.
- Have previous working experience in a highly regulated production environment such as cannabis, pharmaceuticals, medical devices, food/beverage, cosmetics, etc.
- Residency within proximity to the Claresholm, Alberta worksite is an asset.
- Experience specific to the cannabis industry with understanding of other cannabis business operational areas.
- Must have an Alberta Driver’s License.
- Proficient in English, with excellent oral and written communication skills.
- First aid certified and WHMIS certified is an asset.
If you’re looking to make a difference as part of a family in an exciting new industry, you just might be who we’re looking for. Now that you know a little bit about our story, tell us yours.