Our client is a licensed producer (LP) dedicated to producing premium craft flower, with cannabis cultivation facilities across multiple Canadian provinces. 

They are seeking an experienced Quality Assurance (QA) Lead (EU-GMP Programs & AQAP) to join their team onsite at their Fredericton, New Brunswick location.

This role will be essential in further establishing, maintaining, and implementing their pharmaceutical quality management system. They will be the first point of contact within the organization for expertise on EU-GMP standards, compliance, and implementation. 

The QA Lead (EU-GMP Programs & AQAP) will collaborate closely with various stakeholders to ensure compliance with local, European, and company quality assurance requirements. They will act as deputy Quality Person/Responsible Person as per EU-GDP guidelines.

This role will be responsible for development of a project plan to remedy gaps and/or improvements to current operating practices to meet current EU-GMP standards, developing IQ, OQ, PQ protocols, site master files, full implementation of our QMS (Isolocity), and training standards for staff.

Responsibilities will encompass maintaining the Quality Management System, overseeing deviations and complaints, conducting self-inspections, and preparing for GDP/GMP inspections by Competent Authorities.

The ideal candidate will have a strong background in QA management within the legal Cannabis industry, with extensive knowledge of GDP and EU-GMP standards, audits and implementation.

MUST be able to relocate full-time to Fredericton, NB (Relocation will be provided).

MUST be able to pass the Health Canada Security Clearance Process.

Visa sponsorship is offered for qualified QA candidates coming from the European/UK legal cannabis industry.

RESPONSIBILITIES:

• Quality Assurance Management (70%)
• Ensures that all cultivation and processing activities are carried out as per Standard Operating Procedures (SOP), at all times.
• Comprehensive understanding of the Cannabis Act and its Regulations, along with provincial regulations related to cannabis. Must understand the regulatory frameworks and will work with other departments to ensure compliance.
• Comprehensive understanding Eudralex and EU-GMP processes and standards.
• Collaborate with other relevant departments such as operations, sales and marketing to ensure compliance with Health Canada regulations and guidelines.
• Must ensure that all technical documents at site in use are current. All the master documents such as site policy documents and Standard Operating Procedures (SOP) must be controlled and secured in accordance with Good Documentation Practices.
• Maintain SOPs and training manual versioning in Isolocity.
• Review quality agreements with 3rd party customers/external vendors to ensure compliance.
• Responsible for annual audit of SOPs, including where required with Third-Party Partners, such as testing and formulation partners.
• Complete Audit of Suppliers, where applicable.
• Responsible for compliance reporting in CTLS and B300s.
• Responsible for high-level review of records completed by staff and managers in Elevated Signals.
• Responsible for training of staff and managers for compliance related SOPs.
• Responsible for managing and coordinating quality assurance staff, creating department efficiencies and providing leadership support.
• Responsible for coordinating with maintenance, and sanitation staff to ensure record keeping in order.
• Communicate effectively to all levels of management.
• Managing quality standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.
• Responsible for managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards/requirements for worldwide distributions.
• Assures compliance to in-house and/or external specifications and standards, such as GMP, GGP, GPP, GDP, etc.
• Designs methods and procedures for inspecting testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
• Performs internal audits, and vendor evaluation audits on a regular basis to determine quality qualifications. Actively participates in external audits such as Health Canada Inspections.
• Responsible for coordinating annual mock recall.
• Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
• Assists product support areas in gathering and analyzing data.
• Participates in the reviewing of engineering designs to contribute quality requirements and considerations.
• Oversee sample selection and analytical testing for both internal and external CoA purposes.
• Oversee preparation of documents for cannabis transfers along with Assistant QAP and sales team.
• Other duties as assigned.
• Sanitation Management (15%)
• Manage the sanitation team leads.
• Manage the ATP testing program as conducted by Sanitation Technicians.
• Responsible for ensuring the sanitation schedule is maintained.
• Manage staff to ensure labelling of sanitation supplies occurs.
• Manage staff to ensure that sanitized equipment is properly identified.
• Other duties as assigned.
• Shipping/Receiving (15%)
• Release batches that leave the facility.
• Ensure shipping/receiving staff have prepared paperwork required to release shipments.
• Ensure shipping/receiving staff are intaking and releasing working materials into the facility properly, including but not limited to: quarantine requirements, sanitation requirements, documenting of batch codes, ensuring product is both approved and correct.
• Other duties as assigned.

QUALIFICATIONS:

• Bachelor’s degree in Pharmacy, Life Sciences, Engineering, or related field (Master’s preferred).
• 5-7 years in Quality Assurance within the Cannabis (preferred) and/or pharmaceutical/biotech industry.
• Extensive experience with EU GMP and AQAP standards.
• Proven track record in managing and implementing QMS, including pharmaceutical packaging compliance.
• Valid Health Canada Security Clearance or willingness to obtain.
• Quality Management certification (e.g., CQA, CQE) preferred.
• Technical Skills:
• Strong knowledge of EudraLex - Volume 4, Health Canada GMP, and PIC/S Guide to GMP ANNEX 7.
• Proficiency in IQ/OQ/PQ protocols and QMS software (e.g., Isolocity).
• Experience leading QA projects from implementation to operations, addressing gaps to meet EU GMP standards.
• Strong communication and leadership skills, with experience training staff on GMP standards.
• Deep understanding of local, EU, and global quality regulations, including EU GDP guidelines.
• Experience with product registrations and compliance across provinces/countries.
• Strong analytical skills for managing deviations, complaints, and corrective actions.
• Ability to adapt to evolving regulatory requirements and operational needs.

For more open positions check out https://emeraldlanerecruitment.com/