Do you have strong knowledge of GMP, GPP, GACP, SAFR, FDR, CFIA, HC, FDA, EMA, and ICH guidelines? Do you have advanced knowledge of the Cannabis Act, its Regulations, and Physical Security protocols? Do you have strong auditing skills? If so, then this ad is for you!
At Zenabis, our Compliance Manager is responsible for all compliance activities at the Zenabis Stellarton facility and will be responsible for overseeing all communications with Health Canada concerning licensing and regulatory compliance for the facility and its products. They must ensure that the facility is always inspection ready and will manage the submissions of all reporting requirements of the Minister of Health and other Regulatory Authorities.
Duties and Responsibilities
Prepare, submit and maintain facility permits, licenses, and registrations. Manage and maintain the lifecycle for the manufacturing licenses and marketing authorizations
Oversee submissions of cannabis inventory reports to Health Canada Licensing and ensuring these are consolidated with the ERP system
Ensure all notices to authorities are completed correctly and submitted within the timeframe specified in the Cannabis Regulation
Review and advise on all Organizational Security Plans and Physical Security Plans before final submission to Health Canada
Participate in all Health Canada and other Regulatory authority audits
Oversee the execution of internal regulatory compliance audits of all departments and issue audit reports to department heads to ensure audit readiness and conformity with the Cannabis Act, its Regulation, and other regulatory requirements such as GMP, GPP, GACP, SAFR, FDR, CFIA
Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented
Participate in all initial change control meetings to ensure all proposed changes follow legal guidelines and internal policies and procedures
Proactively reviews procedures and reports periodically to identify trends, risks and non-conformities
Support the development and implementation of company policies as they relate to Compliance
Oversee all cannabis transfer requirements for documentation are met prior to authorization
Monitor and participate in all security and quality investigations relating to unexplained cannabis losses, gains or theft incidents
Collaborate with each department and support the implementation of Corrective and Preventive Actions (CAPAs)
Participate in management meetings to remain abreast of all current and future compliance risks
Develop compliance training programs and provide advice and training to develop facility personnel in matters related to Compliance
Bring awareness of any regulatory issues, updates and best practices to senior leadership and facility leads
Prepare facility compliance reports for senior management and external regulatory bodies when required
Maintaining customer confidence and protecting operations by keeping the information confidential
Other duties as assigned
Qualifications
University degree required; Business or Sciences preferred
8+ years of experience in a regulated GMP environment, 3+ years in a lead/Management role
Ability to travel within Canada
Problem-solving and decision-making skills
Excellent interpersonal skills (dynamic, strong relationship builder and influencer)
Strong ability to adapt to change
Demonstrate excellent verbal and written communication/presentation skills
Exceptional organizational skills - manage multiple tasks and meet deadlines
Strong analytical and professional judgment skills
Ability to research, analyze and synthesize information from various sources
Ability to demonstrate discretion, tact and sound judgment, especially when reviewing sensitive or confidential information and determining the appropriate course of action
Works well alone and in a team environment
Knowledge working with computerized systems such as ERPs, etc
Bilingual – English and French
Salary: Commensurate with experience and qualifications
Security Clearance: Security Clearance is a requirement for this position
Working Hours: Salaried Position: Monday – Friday, 8:00 am – 5:00 pm. Weekend work may be necessary as per the direction of your direct report
