About the Role
This position presents a unique opportunity for quality assurance professionals to show their leadership skills and assist the Director of Quality Assurance with establishing a Quality Management System utilizing software and cloud-based technologies in order to launch an official project beginning in Q1 of 2022.
The ideal candidate will have a good understanding of the differences in GMP standards between industries such as pharmaceuticals, food and beverage, cosmetics, controlled substances, and health and wellness products. The application of a wide spectrum of regulatory knowledge will be tasked with the management of regulatory and compliance monitoring.
The first product to be manufactured will be a Psilocybin Mushroom medicinal formulation. PurMinds has a Dealer’s License for Controlled Substances issued by Health Canada and will be developing products derived from plant medicine (such as psychoactive-containing plant sources), but will not be producing natural health products or “nutraceuticals”.
This is an opportunity for a quality assurance professional to have involvement in several areas of the quality management system establishment.
The Quality Assurance Manager is responsible for providing leadership to ensure that the established Quality Management Systems are successfully executed in compliance with the Controlled Drugs and Substances Act (CDSA), and Food and Drug Regulations (FDR), where applicable. This role requires significant cross-functional relationship building between working groups in a small team and is intended to drive actions supporting operational excellence.
Compensation and Benefits Highlights
• Competitive base salary, short-term and long-term incentive plans
• Medical benefits including dental and vision
Assess Your Candidacy
• BSc. in biology, biotechnology, chemistry, or related life science with minimum 5 years’ related experience;
• Experience in quality systems such as DMAIC, CAPA, etc.
• Excellent knowledge of Good Documentation Practices and how this translates to modern platforms that are electronic
• Good presentation skills, dynamic, and well-organized
• Proactive and enjoys working as part of a team
• Strong command of the Canadian regulations; an ideal candidate would also have some knowledge of the American regulations
• Strong written and communication skills and ability to communicate effectively with regulatory bodies and the operations team in order to understand strategic goals
• Valid G class driver’s license and ability to travel to Bolton, Ontario
Ideal, Not Required
• Experience managing regulatory aspects of a dealer’s license for narcotics and/or other high-interest psychoactive substances
• Management experience in pharmaceutical quality assurance and/or medicinal cannabis environments
• Some research and development experience
• Previously granted security clearance with Health Canada
• Ensure operations are executed in compliance with the Quality Management System
• Drive continuous improvement through leading cross function teams, to address process improvement, system improvement, new regulations/expectations, new business needs and training improvements.
• Prepare, review and approve SOP, master production documents, data sheets, forms, and other GPP and GMP related documents.
• Schedule and perform internal and external audits
• Manage the deviation system and work closely with the production and production support teams to determine root causes, corrective, and preventive actions to prevent deviation recurrences
• Manage the CAPA system and ensure that all regulatory and site CAPAs are assessed and closed on time
• Manage the change control system and ensure that all changes that impacting the product quality are assessed and controlled
• Conduct GMP, GPP, and site SOP trainings for new and existing employees
• Conduct self-inspections and participate in the regulatory inspections
• Manage the supplier qualification program and conduct supplier audits
• Review Batch Records and release products to the market or for the clinical trials
• Perform the product sampling for release, retain, and stability
• Perform the GMP and GPP walkabouts and ensure that the production activities are in compliance with the regulatory regulations
• Participate in the product recalls and ensure that all products are reconciled, recalled, put on hold, and destroyed.
• Participate in the protocol and report preparation for the equipment qualification, cleaning validation, and process validations.
• Manage the site pest control programs and ensure that the pest control inspections are performed periodically
• Perform the environmental monitoring sampling and send the samples to the internal or external labs for microbial analysis
• Perform the city water sampling and send the samples to the internal and external labs for analysis
• Manage the product waste and ensure that all Cannabis and Controlled Substances products destructions are communicated to Health Canada for destruction authorizations.
• Accompany the production personnel in the Cannabis and Controlled Substances presence areas during the cultivation and processing of these products
• Performs other duties as assigned
What PurMinds Offers
A generous compensation package including an equity stake in PurMinds' success. Our headquarters are located in Toronto, Ontario - a burgeoning hub for start-ups that have a mission to change the world.
At PurMinds NeuroPharma, we are redefining drug discovery and development for neurodegenerative diseases. To be successful, we have identified steps in the process to innovate - from cost-effective large scale rapid screening, to using more accurate techniques in preclinical validation, we utilize a comprehensive approach to drug discovery and development using multi-omics analyses to completely change what it means to develop neurodegenerative therapeutics.
We are a growing company that uses cutting-edge discovery tools to ensure that the therapeutic candidates in our pipeline exhibit the best chances of success throughout the development process. Our wholistic approach regarding omics analyses means that we have the ability to inform both of our efforts in discovering new therapeutic targets and developing promising candidates.
To change the drug discovery and development status quo takes more than the best technology. Our team of renowned experts in neurodegenerative diseases has the ability to solve the most complex problems in traditional neurodegenerative drug discovery and development, and are up for any challenge. People are the key to our success. We are looking for someone that has the drive, enthusiasm and curiosity to learn to help us succeed.