We are seeking a Director of Quality Assurance & Regulatory Affairs to strategically manage development, implementation, and ongoing monitoring of the quality assurance and control systems in compliance with the Cannabis Act and Health Canada.
Reporting to the COO, you will help build and maintain a culture of quality across all levels of the organization. A passion for quality and a willingness to collaborate with all stakeholders is essential.
Motif Labs is a licensed cannabis extraction facility located in SW Ontario. Motif operates as a business-to-business enterprise, offering toll processing and contract manufacturing services to Licensed Producers (LP’s) and 3rd Party Brands. Motif is positioned for significant growth throughout 2021, and we are seeking dynamic and professional individuals to join our team. Motif prides itself on Integrity, Collaboration and Quality, and these core values are at the center of everything we do.
Quality Assurance and Quality Control
- Oversee the implementation and up keep of the Preventative Control Plan
- Work with testing labs, biomass suppliers and clients to ensure Quality Agreements are comprehensive and accurate
- Ensure clear traceability throughout the organization, from inputs to finished goods; identify opportunities to improve the use of existing traceability, inventory and document management platforms
- Identify and lead improvements to the quality management system, ensuring full regulatory compliance
- Lead the execution of CAPA, deviation, change control, and document management platform
- Coordinate, execute and improve upon internal self-audit program, continuously driving a strong QA/QC culture across all levels of the organization
- Oversee the development and maintenance of Standard Operating Procedures, and other controlled documents
- Lead the implementation of environmental monitoring program, including but not limited to, sanitation validation, temperature mapping, air cleanliness etc.
- Oversee process updates and product development activity from a quality assurance perspective
- Coordinate and implement process and equipment validation studies
- Working with the QAP and RP, represent the company in all regulatory audits including inspections performed by: Health Canada, Prospective Clients, CRA, Provincial Boards.
- Maintain a current understanding of the Cannabis Act and investigate all relevant changes to the act; report any changes that impact core operations to the executive team
- Ensure timely response to any audit observations or requests pertaining to company licenses
- Ensure all changes, amendments or updates to licenses are written with extreme attention to detail
- Other duties as assigned
- Manage a growing and dynamic QA/RA team
- Ensure that the QA/RA organization is growing adequately to support the increasing growth and complexity of the business
- Ensure that all expansion and growth activity is being executed with a focus on compliance
- Trend and analyze QA issues, escalating to upper management as required
- University degree in sciences, engineering, pharma, medicine with +10 years of experience in QA/RA leadership positions within Cannabis, Pharma, or Food industries
- Experience with managing a strong team of professionals with a focus on growth, culture and development
- Direct experience in cannabis extraction, edibles, beverage or other 2.0 product manufacturing considered an asset
- Experience with working in a highly regulated environment (CFIA, GMP, FDA, GPP, etc.)
- Deep experience with managing regulatory audits, client inspections
- Process driven leader with a strong ability to manage complex processes and competing priorities
- Exceptional oral and written communication skills
- Security clearance preferable