Project Lead- EU-GMP

Our client is a licensed producer dedicated to producing premium craft flower, with cannabis cultivation facilities across multiple Canadian provinces. They are seeking an experienced EU-GMP Project Lead to join their team onsite at their Fredericton, New Brunswick location.

This role will be essential in leading the organization to achieve and maintain EU-GMP certification. The EU-GMP Project Lead will serve as the primary quality representative for certification projects, inspections, and regulatory interactions, and will act as the subject matter expert on EU-GMP requirements across the organization.

This role will be responsible for assessing existing quality systems against EU-GMP standards, developing remediation plans to close identified gaps, overseeing qualification and validation activities, and developing the Site Master File and other documentation required for certification. Working closely with the COO and cross-functional teams, the EU-GMP Project Lead will coordinate inspection readiness, manage CAPAs, and build a sustainable EU-GMP quality culture.

The ideal candidate will have Quality Assurance experience in a regulated industry, with direct involvement in EU-GMP quality systems and certification projects.

• Able to relocate full-time to Fredericton, New Brunswick (relocation will be provided).
• Able to pass the Health Canada Security Clearance process.
• Minimum 3 to 5 years of Quality Assurance experience in a regulated industry, with direct involvement in EU-GMP/GMP quality systems.
• Experience supporting or leading EU-GMP certification projects, regulatory inspections, customer audits, and CAPA management.

• Lead and coordinate all activities related to achieving and maintaining EU-GMP certification.
• Serve as the primary quality representative for EU-GMP certification projects, inspections, and regulatory interactions.
• Conduct gap assessments against EU-GMP standards and develop remediation plans to address deficiencies.
• Collaborate with cross-functional departments to implement EU-GMP compliant processes and practices.
• Act as the subject matter expert on EU-GMP requirements and provide guidance to departments on compliance-related matters.

• Review and assess existing quality systems, procedures, and records to ensure alignment with EU-GMP requirements.
• Develop, revise, and approve quality documents required for EU-GMP compliance, including SOPs, validation protocols, reports, and quality agreements.
• Develop and maintain the Site Master File and other regulatory documentation required for certification.
• Support batch record review and quality oversight activities as required for EU-GMP compliance.
• Review quality metrics and compliance trends to identify risks to certification readiness, and participate in risk assessments and quality risk management activities in accordance with EU-GMP expectations.
• Oversee and support qualification and validation activities, including equipment, utilities, computerized systems, cleaning, and process validation.
• Support supplier and service provider qualification activities required for EU-GMP certification.

• Coordinate and participate in internal audits to assess readiness for EU-GMP inspections.
• Coordinate inspection readiness activities, including documentation preparation, responses to auditor requests, and inspection logistics.
• Prepare and support responses to audit observations, inspection findings, and regulatory commitments.
• Track and monitor corrective and preventive actions (CAPAs) arising from audits, assessments, and compliance reviews.

• Ensure all cultivation and processing activities are carried out…