Senior Manager, Quality Assurance
- Paris, ON | Full-time
Reporting directly to the VP Quality & Regulatory Affairs the Senior Manager, Quality Assurance is responsible for ongoing quality assurance and compliance of licensed products as well as products in development. The individual will work with a high level of autonomy and authority for decision making and is the delegate for the VP Quality & Regulatory Affairs. He/she ensures that a compliant and effective risk-based Quality Management System exists and is responsible for continuous improvement activities and enabling innovation within quality assurance.
- Provides leadership of Quality team assuring that processes (cultivation, processing, packaging & labelling, analytical testing, destruction, development) are executed effectively and compliant and that resources are planned and utilized effectively
- Develop and maintain an efficient and effective risk-based Quality Management System in compliance with regulatory requirements and industry-recognized best practices
- Drive continuous improvement and Operational Excellence culture of the Quality System
- Ensure site inspection and audit readiness at all times and lead inspections and audits
- Train and coach all staff to the highest standards of quality, compliance and technical competency
- Engage in proactive relationships with Health Canada and other global regulatory authorities to facilitate the advancement of the Company’s objectives
- Creates and maintains a quality culture of transparency and efficient communication of quality-related matters to achieve and maintain the desired high level across the Company’s development and manufacturing operations.
- Conduct internal audits and facility walkthroughs, including sanitation, equipment, validation and HVAC
- Approve batch records, deviations, CAPAs and change controls
- Participate in the preparation and maintenance of regulatory documents, including licences, amendments and monthly reports
- Perform other related duties as required.
Experience / Education
- Degree in a related scientific field (i.e. pharmaceutical, biotechnology, science, chemistry, microbiology and biology) and ability to be certified as QAP
- 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 MMPR, ACMPR and Cannabis Act
- Strong leadership and influencing skills, particularly in situations where direct manager authority does not exist
- Ability to work independently, and as part of a team and collaboratively across the organization
- Ability to prioritize and schedule daily activities, manage multiple priorities, and requests under tight time constraints
- Excellent analytical and problem-solving skills
- Outstanding communication skills, written and verbal
- Clean police background check
- Customer-focused, results-oriented with excellent organizational skills.
- 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 A/RPIC status as required through Health Canada
Note: The chosen applicant will be required to successfully complete background and reference checks. 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.