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PURPLEFARM

EU-GMP Project Lead

Fredericton, NB, Canada

Full-time

Apply About employer

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Job details

Job type: Full-time
Apply by: Oct 29, 2026
Experience: 3-5 years of Quality Assurance experience in a regulated industry, with direct involvement in EU-GMP/GMP quality systems.
Posting language: English
Posted: Sep 29, 2026

Original job description

The Role

The EU-GMP Project Lead will lead and coordinate activities related to achieving and maintaining EU-GMP certification, serving as a key quality representative for certification projects, inspections and regulatory interactions.

Responsibilities

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.
Review quality systems, procedures and records for alignment with EU-GMP requirements.
Conduct gap assessments and develop remediation plans to address deficiencies.
Collaborate cross-functionally to implement EU-GMP-compliant processes and practices.
Develop, revise and approve quality documents including SOPs, validation protocols, reports and quality agreements.
Oversee and support qualification and validation activities for equipment, utilities, computerized systems, cleaning and processes.
Coordinate and participate in internal audits and inspection-readiness activities.
Track CAPAs arising from audits, assessments and compliance reviews.
Support supplier and service-provider qualification activities.
Ensure training programs meet EU-GMP requirements and coordinate related training.
Review quality metrics and compliance trends and participate in quality risk-management activities.
Support batch-record review and quality oversight activities required for EU-GMP compliance.
Support development and maintenance of the Site Master File and other regulatory documentation.
Monitor updates to EU-GMP regulations, guidelines and industry best practices.
Support compliance with the Cannabis Act, its Regulations and applicable provincial cannabis regulations.
Prepare and support responses to audit observations, inspection findings and regulatory commitments.
Provide regular updates to the COO on certification progress, compliance risks and project milestones.
Act as a subject matter expert on EU-GMP requirements and provide guidance across departments.
Perform other duties as assigned.

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.
3-5 years of Quality Assurance experience in a regulated industry, with direct involvement in EU-GMP/GMP quality systems.
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 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.
Strong communication and leadership skills with cross-functional experience.
Proficiency with Microsoft Office and electronic Quality Management Systems (eQMS).
Ability to work independently with strong attention to detail, integrity and commitment to continuous improvement.

What You Can Expect at PURPLEFARM

At PURPLEFARM, our people are part of how we grow. We offer opportunities to learn, take on new responsibilities and contribute across a growing organization.

Competitive Compensation & Benefits Competitive compensation and employee benefits for eligible positions.

Learn & Grow Opportunities for hands-on training, cross-training and developing new skills as part of your role.

Work as a Team A collaborative environment where cultivation, operations, quality and other teams work together.

Make an Impact The opportunity to contribute to how we grow, improve our processes and build what comes next at PURPLEFARM.

Safety & Quality A workplace built around established procedures, quality standards and a commitment to working safely.

Apply

Interested candidates can apply by email to shannon@purplefarmgenetics.com.

PURPLEFARM is an equal opportunity employer. Applicants may request accommodation during the screening or interview process.

Apply for this role

Apply About employer

More about this job

Responsibilities

Lead EU-GMP certification and ongoing compliance, including gap assessments, remediation, quality documentation, validation, audits, CAPAs, and inspection readiness. Coordinate cross-functional quality activities, advise teams on regulatory requirements, and report certification progress, risks, and milestones to the COO.

Requirements

Requires a bachelor's degree in a relevant science discipline or equivalent education and experience, plus 3–5 years of Quality Assurance experience in a regulated industry with direct EU-GMP/GMP quality systems involvement. Candidates should know EU-GMP, Health Canada Cannabis Regulations, GPP, and ICH guidelines, and have experience with inspections, audits, CAPAs, validation, controlled documents, and eQMS.

Skills

EU-GMP Compliance
Quality Assurance
Quality Management Systems
Gap Assessments
CAPA Management
Validation and Qualification
Regulatory Inspections
Internal Audits
Document Control
Change Control
Deviation Investigations
Risk Assessments
Supplier Qualification
Batch Record Review
Cross-Functional Leadership
Electronic Quality Management Systems

Benefits

Competitive Compensation
Employee Benefits
Hands-On Training
Cross-Training
Skill Development

Visa sponsorship

Not detected in the job text

Hiring contact email

shannon@purplefarmgenetics.com

Keywords

EU-GMP
Health Canada Cannabis Regulations
Good Production Practices
ICH Guidelines
Quality Assurance
Quality Management Systems
CAPA
Gap Assessment
Remediation Plans
Regulatory Inspections
Customer Audits
Change Control
Deviations
Investigations
Risk Assessments
Document Control
Validation
Equipment Qualification
Supplier Qualification
Training Programs
Batch Records
Site Master File
Cannabis Act
Standard Operating Procedures
Validation Protocols
Quality Agreements
Electronic Quality Management Systems
Microsoft Office
Inspection Readiness

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