EU-GMP Project Lead & AQAP
Full-time, Onsite (Relocation Offered)
Fredericton, New Brunswick, Canada
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.
MUST-HAVE REQUIREMENTS
- 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.
KEY RESPONSIBILITIES
EU-GMP Certification Leadership
- 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.
Quality Systems & Documentation
- 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.
Qualification, Validation & Supplier Management
- 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.
Audits, Inspections & CAPA
- 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.
Regulatory Compliance, Training & Reporting
- Ensure all cultivation and processing activities are carried out according to Standard Operating Procedures (SOPs) at all times.
- Apply a comprehensive understanding of the Cannabis Act and its Regulations, along with provincial cannabis regulations, working with operations, sales, marketing, and other departments to ensure compliance with Health Canada regulations and guidelines.
- Ensure training programs meet EU-GMP requirements and coordinate EU-GMP training for staff.
- Monitor updates to EU-GMP regulations, guidelines, and industry best practices, and assess their impact on the compliance program.
- Provide updates to the COO twice per week on certification progress, compliance risks, and project milestones.
KEY DELIVERABLES
- Successful EU-GMP certification and inspection outcomes.
- Closure of identified EU-GMP gaps and CAPAs.
- Completion of validation and qualification programs.
- Inspection-ready quality documentation and records.
- Ongoing compliance with EU-GMP standards and expectations.
- Development of a sustainable EU-GMP quality culture across the organization.
QUALIFICATIONS
- Bachelor's degree in Science, Pharmacy, Microbiology, Chemistry, Biology, or a related discipline (or an equivalent combination of education and experience).
- Minimum 3 to 5 years of Quality Assurance experience in a regulated industry (pharmaceutical, cannabis, biotechnology, medical device, or food manufacturing), with direct involvement in EU-GMP/GMP quality systems.
- Demonstrated knowledge of EU-GMP, Health Canada Cannabis Regulations, Good Production Practices (GPP), and ICH guidelines.
- Experience supporting or leading EU-GMP certification projects, regulatory inspections, customer audits, and CAPA management.
- Strong understanding of quality systems, including change control, deviations, investigations, risk assessments, document control, validation, supplier qualification, and training.
- Experience reviewing and approving controlled documents, batch records, SOPs, validation protocols, and quality records.
- Excellent organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities and meet project timelines.
- Strong communication and leadership skills, with experience training employees and collaborating cross-functionally with Production, Cultivation, Operations, and Quality teams.
- Proficiency with Microsoft Office and electronic Quality Management Systems (eQMS).
- Ability to work independently while maintaining a high level of attention to detail, integrity, and commitment to continuous improvement.
Compensation
In accordance with New Brunswick's Pay Transparency Act, the expected base salary range for this position is $75,000 to $105,000, commensurate with education and experience. Relocation and visa support are offered.
Equal Opportunity Statement
Emerald Lane Recruitment is committed to advancing equity and inclusion across the global cannabis industry. We welcome applications from qualified candidates of all backgrounds and experiences.
