Specialist, GxP Compliance

Overview

As our GxP Systems Compliance Specialist you are accountable for development and ensuring site compliance for GxP systems with focus on internal auditing, training, risk management, qualification and validation to ensure GMP, GACP and IMC-GAP certification, product safety, customer satisfaction and regulatory compliance. This is a dynamic role, providing a unique opportunity in cannabis cultivation, processing, quality assurance systems, and Cannabis Regulations.

This supports the maintenance and leads the improvement of Quality Management System to ensure the quality, safety, and complete traceability of batches of cannabis and cannabis products. The role provides ground-level analysis of potential risks to product quality and safety and provides recommendations to senior management to reduce or eliminate risk; while defending product quality and safety at every step of the production process to ensure we deliver on our quality goals within customer expectations and regulatory compliance guidelines.

• Establishing, implementing and maintaining an efficiently integrated and robust quality risk management program in compliance with ICH Q9
• Creating and implementing quality risk management tools, standards and procedures for all relevant aspects of our organization
• Mapping and executing QRM plans and reports for GxP activities
• Facilitating/guiding risk management for GxP activities, including formulation of an appropriate risk question, managing external resources, and training and mentoring team members on QRM
• Facilitates equipment and room qualification and process/cleaning/CSV validation processes into site QMS through collaboration with respective departments for requalification/revalidation purposes and for increasing GMP capacity at the site
• Interfacing with quality, regulatory, and leaders to establish clear and consistent requirements and risk management activities related to intended use, user, environment, and product performance over a broad and complex portfolio of products
• Selecting the most appropriate and engaging training methods or activities to ensure the best learning outcomes
• Conducting an organization-wide training needs assessment; identifying skills or knowledge gaps that need to be addressed
• Partnering with our Human Resources team to create the most valuable onboarding experience
• Mapping out GxP training plans and programs
• Assessing instructional effectiveness and analyzing the impact of training
• Development of QMS with feedback from internal/external audits, complaints, deviation and CAPA’s
• Supporting development and maintenance of training needs matrices with internal stakeholders
• Establishing and updating the QMS framework processes and robust quality systems management program in compliance applicable GxP and customer requirements
• Develop and update the Internal Audit program, ensuring compliance to systems, product and process audits and collaborating with internal stakeholders to close respective corrective actions
• Coordinate and collaborate with cultivation, and processing departments to communicate risks and recommended corrective actions to support GACP, and IMC-GAP compliance and successful recertification.

• Supporting, maintaining, monitoring QMS framework processes and robust quality systems management program in compliance applicable GxP requirements
• Leading the Internal Audit program, ensuring compliance to systems, product and process audits and collaborating with internal stakeholders to close respective corrective actions
• Continuously improving the QMS in a phase appropriate manner to from QMS control systems outputs to gain agility, simplicity, efficiency, while preserving high quality standards and meeting GxP requirements and expectations
• Overseeing the performance and effectiveness of the QMS programs, as well as supporting Quality Risk Management, Training, and Data Integrity, as needed
• Ensuring timely and accurate reporting via Quality Review Boards/Management Review on the performance of the QMS, along with associated required improvements
• Supporting GxP inspections and audits from both regulatory authorities and partners and supporting drafting of follow-up responses for all aspects of the business
• Collaborating with training teams to provide insight and guidance on the planning and implementation of quality system related training
• Providing cross functional quality leadership and acting as a GxP compliance subject matter expert
• Evaluating department goals/objectives, utilizing critical thinking, and applying problem-solving techniques to improve and sustain product quality and process effectiveness in the overall QMS lifecycle
• Coordinating risk management activities and overseeing the QRM system to enable timely identification and communication of quality and compliance risks, and appropriate mitigation and risk reduction actions
• Leading periodic reviews of QRM efforts to foster…