The Quality Systems and Compliance Manager is primary responsible for developing and implementing robust quality management systems, and for streamlining the site quality management system (QMS) processes. Their role is to continuously improve the QMS and ensure it is implemented effectively by trending data and using metrics to manage performance. The Quality Systems and Compliance Manager will also be responsible for all regulatory compliance activities on site. The Quality Systems and Compliance Manager provides effective leadership and management of the Quality Systems and Compliance team on site.
Duties and Responsibilities
Performs site gap assessments against new QMS policies and leads the implementation of these policies at the site.
Process owner for site training and ensures training is effectively coordinated and implemented. Implements training performance metrics and issues periodic training compliance reports
Executes and manages the self-inspection program within Zenabis Atholville including the development of an audit universe, audit planning and tracking of corrective and preventive actions to ensure timely completion.
Supports and participates in 3rd party and regulatory body inspections as an SME. Manages the site inspection readiness preparation, inspection logistics and execution, including the inspection response process.
Ensures the Risk Management process is deployed at site, maintains the risk register and chairs the site risk management meetings. Responsible for the coordination, preparation and scribing of the monthly quality management review meeting. Ensures meeting minutes are shared and archived and that actions from the meeting are followed upon.
Ensures that Annual Product Quality Reviews for products manufactured under GMP are prepared according to schedule.
Ensure that quality and service agreements are prepared and in place between Atholville and other Zenabis sites or contractors when Atholville is the Contract Giver. Reviews and approves quality agreements from other Zenabis sites when Atholville is the contract acceptor.
Acts as the System owner for the eQMS application in Atholville that manages quality system records, actions, and logs. Ensures that the monthly site quality system metrics and reports are created and trended. Follows up on outstanding or overdue tasks.
Reports quality system and compliance metrics in the monthly quality management review meeting.
Identifies and implements new technologies to improve the compliance and efficiency of quality systems’ operations.
Responsible for the Atholville supplier audit program including metrics, and the preparation and review of Supplier Quality Agreements. Liaise with suppliers to resolve any supplier complaints in a timely manner.
Ensures facility permits, licenses, and registrations are prepared, submitted in a timely manner and maintained to current standard. Manage and maintain the lifecycle for the site manufacturing license.
Reviews and approves submissions of cannabis inventory reports to Health Canada Licensing and ensures these are consolidated with internal systems.
Participates in all security and quality investigations relating to unexplained cannabis losses, gains, or theft incidents.
Supervises Quality Systems and Compliance employees and provide guidance and leadership.
Manages Quality Systems and Compliance employee-related activities including recruitment of staff and performance management and development.
Ensures that the required initial and continuing training of the Quality Systems and Compliance department is performed.
A bachelor’s degree in chemistry, biology, health or other technical science.
A minimum of 8 years of experience in pharmaceutical or food based GMP operations working in Quality.
3+ years in a Quality leadership role with demonstrated effectiveness to recruit and train a team as well as provide continued guidance, mentorship and support to staff.
Strong knowledge of GxP and other Health Canada and EU regulations. Advanced knowledge of the principles and application of ICH Q9 and Q10 is considered an asset.
Excellent knowledge of the Cannabis Act and its Regulations.
Direct experience in GMP auditing and Health Authority inspection management including the preparation of responses and corrective action plans.
Demonstrated ability to perform long-term project planning, team building and operational excellence.
Excellent attention to detail and consistent high level of accuracy
Ability to work as a team member and to manage teams fairly and efficiently
Previous Health Canada Security Clearance and work experience with a Canadian Licensed Producer (LP) is considered an asset.
Working knowledge of an eQMS system is an asset
Proficient in English (proficient or functional in French is considered an asset)
Excellent follow-up and organizational skills.
Excellent oral and written communication skills with strong technical writing experience.
Excellent interpersonal skills, management and leadership skills.
Ability to work independently, prioritizes multiple projects, addresses multiple issues, and handles multiple deadlines, in a hands-on environment.
Solid decision-making skills and critical thinking ability.
Commensurate with experience and qualifications.
Security Clearance may be requested for this position.
Monday – Friday, 8:00 am – 5:00 pm.
This position will require after hours or extended hours based on activity.
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