Rubicon Organics’ mission is to grow the best cannabis on earth and for the earth and today we are doing just that out of our state-of-the art greenhouse facility located in Delta, B.C. We are growing and expanding quickly, with national distribution across Canada with 5 cannabis brands, as well as upcoming export partnerships. We are launching 20-30 new products each quarter as we bring exciting new genetics and extracted products to market in Canada. We are also excited to bring our portfolio of super premium organic cannabis brands to the international market.
We’re looking for a talented Senior level GMP QA (Good Manufacturing Practices - Quality Assurance) professional to help us deliver our mission and have a big impact in this high growth industry.
This is an opportunity to take everything you’ve learned in your quality career and continue to grow within a nimble multinational company, leaving a huge legacy in your wake.
Reporting to the Quality Assurance Person (“QAP”), and working closely with GMP Project Manager, the GMP Quality Manager will be responsible for the overall success of EU-GMP certification and compliant continuous operations.
Provide gap analysis on existing QMS system in relation to EU-GMP and work on raising the standards and gap closures within stipulated times.
Responsible for all aspects of EU-GMP quality assurance and quality control, including providing oversight of facility and equipment qualification.
Review batch record and ensures the records are complete as per GACP, EU-GMP & GDP standards.
Apply risk-based review processes for EU-GMP documentation by identifying key elements such as critical quality attributes, critical process parameters, and critical material attributes suitable for the phase of development.
Define, design and implement SOPs and take ownership over their continuous improvement
Train new employees and provide refresher training on EU-GMP as required and international regulations and related SOPs.
Create internal and client-specific certificates of analysis, certificate of manufacture and compliance, and other documents requiring product release.
Lead customer complaint investigations in tandem with the Quality Control Team, including the performance of investigations, documenting results of investigations of customer complaints, non-conformances, and assist with OOS investigations related to international clients.
Perform self-inspections and assists with customer audits.
Maintain vendor qualifications, material approvals and risk assessments.
Prepare the site for EU GMP audits and lead observation management and responses.
Perform vendor qualifications on external companies and ensure suppliers and contract manufacturers are meeting standards and specifications.
Ensure that documentation, complaints, deviations, non-conformances, investigations, corrective and preventative actions, and change control are performed according to quality and regulatory requirements.
Perform PQ, IQ and OQs.
Initiate audit programs (regulatory, internal and third-party).
Assists the QAP and QA Manager in managing the QMS.
Complete all other tasks related to the position, as assigned by the Quality Assurance Manager or QAP
Experience in a GMP environment is a requirement.
10+ years of experience in a quality position within the pharmaceutical, natural health product or cannabis industry.
Experience establishing EU-GMP compliance at a production facility.
Experience attaining EU-GMP certification and conducting audits with regulators.
Sound knowledge and experience with global GMP regulations, principles and guidelines, current industry standards, best practices, and methodologies.
Knowledge of cannabis quality metrics and cannabis regulations.
Experience in an ISO: 9001, ISO: 13485, ISO: 17025 environment.
Strong verbal and written communication skills.
Ability to provide proactive QA inputs during changes in policies, adapt to changes and work with teams and employees with various skillsets for smooth transition to changes is required.
Excellent attention to detail.
Proven analytical, creative thinking, and adept at solving problems.
Minimum Master’s degree in a science-related field
Be available to work some odd and long shifts, if needed.
Proven track record of success in a high-pressure, fast-paced environment.
Ability to prioritize work and meet deadlines is required.
Strong cross-functional leadership.
Health Canada security clearance or ability to be security cleared is required.