Quality & Compliance Manager
- Paris, ON | Full-time
- Develop and implement a strong Quality Management System that meets relevant quality, GMP compliance, auditing and risk standards, which covers Production System, Facilities & Equipment System, Materials System, Packaging & Labeling System, Quality System, Laboratory Control System and applicable computer systems / validation.
- Approve and manage all company Standard Operating Procedures (SOPs).
- Supervision and representation at Health Canada Inspections/ Audits on behalf of the License Holder.
- Oversee all activities in related to cannabis product such as, production, processing, packaging & labeling, analytical testing and releasing etc.
- Evaluate, perform site audit and approve cannabis related suppliers and vendors on behalf of the License Holder.
- Develop company training program to ensure all employees are adequately and job specifically trained and adhere to SOPs and CR.
- Ensure all processes are managed to an appropriate level of record keeping compliance to support the desired state of control.
- Set up validation protocols and reports including but not limited to Process Validation, Cleaning Validation and Method Validation to ensure production consistency.
- Set up Environmental Monitoring and Stability Studies Program.
- Ensure all levels of change are reviewed, approved, validated (if applicable) and documented prior to implementation.
- Approve analytical testing specification for water, raw material, packaging material and finished marijuana product etc.
- Oversee Out of Specification (OOS) result with root cause investigation, risk assessment and associated Corrective and Preventive Action (CAPA).
- Assure all cannabis products maintain intact product quality and integrity before they are made available for sale.
- Approve and release cannabis products for sale based on analytical testing conformance of Finished Product Specification and compliance with Good Manufacturing Practice (GPP) operations, as well as QA and government standards, including review of Batch Production Record, Certificate of Analysis (CofA) and Labelling.
- Approve of packaging components, immediate containers and label artwork.
- Lead and conduct the internal self-audit and Annual Product Quality Review.
- Handle with quality complaint investigation, recall reporting, pharmacovigilance assessment (i.e. post-marketing adverse reactions and events reporting) and product annually summary reporting etc.
- Prepare and compile all documents of GPP production, quality control, record keeping method and security measure aspects etc. for regulatory applications (i.e. Submission, Renewal and Amendment of Cannabis Licenses).
- Obtain and maintain Cannabis Licences and effective status.
- Liaison and response to Health Canada with licensing and RA matters involving cannabis product.
- Assure domestic and international (i.e. import / export distribution) regulatory requirements are considered in all facets of the quality management system.
- Manage of regulatory affairs electronic and paper files archiving and storage.
- Oversee the Cannabis destruction method / activity implementation to ensure regulatory compliance.
- Oversee and advise on Cannabis inventory control implementation including theft and unusual waste & lost reporting to ensure regulatory compliance.
- Oversee and advise on security & safety of packaging, logistics flow and shipping to ensure regulatory compliance.
- Provide guidance and advice on product evaluations, site design and drawing on expertise.
- Oversee client registration and permitted activities (i.e. possession, production, sale & provision and distribution etc.) in meeting regulatory requirements.
- Coordinate and qualify regulatory documents involved with transaction, sale or provision of bulk Cannabis and / or starting Cannabis material to the other License Holder or legitimate parties.
- Ensure compliance of FDA and CR prohibition in regard to Cannabis advertising and labeling.
- Provide appropriate mentoring and training, appraisal of performance, reward and disciplining to direct reports as well as address complaints and resolve problems.
Experience / Education
- Bachelor’s degree in a related scientific field (i.e. pharmaceutical, biotechnology, science, chemistry, microbiology and biology) with regulatory discipline required.
- 5 to 10 years hands-on and working experience in a GMP-focused quality and regulatory related position in food or pharmaceutical industry environment or equivalent.
- 3+ years of experience managing quality systems and leading direct reports.
Skills & Abilities
- Understanding of the various Cannabis Regulations including Cannabis Act.
- Demonstrated ability to lead and manage within a complex, multi-site, matrix organization.
- Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required.
- Strong leadership and influencing skills, particularly in situations where direct manager authority does not exist.
- Experience building a high-performance team, managing the performance of team members with varying levels of skill and experience, and mentoring high potential individuals to achieve greater impact on the organization.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- CR, FDA, GMP
- Quality Control/Quality Assurance/Regulatory Affairs
- Health Canada Auditing
- Microsoft Office Suite
- Windows Computer literacy
- Ability to work independently and efficiently with little supervision
- Ability to obtain and maintain security clearance status as required through Health Canada
We appreciate the interest by all candidates however we will be contacting those that best fit the requirements.
Aleafia Health welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. If you are selected to participate in the recruitment process, please inform Human Resources of any accommodations you may require. Aleafia Health will work with you in an effort to ensure that you are able to fully participate in the process.