The Quality and Compliance Manager is responsible for managing and enforcing all quality assurance and compliance management (QA/QC) operations at GTI’s Paterson, NJ production facility. Specifically, the QA/QC Manager will play a key role in upgrading or developing and implementing GTI’s quality assurance policies and standard operating procedures. This role will be including compliance, development and implementation of HACCP programs, product quality tracking systems, FDA standards, ingredient management programs, allergen and sanitization management programs, product safety practices, internal and external audits, etc. The individual will also ensure compliance with all GTI Corporate operating procedures, as well as applicable federal, state, county, and municipal laws, regulations, ordinances, and regulations.
- Oversee the facility’s QA/QC department and ensure all employees understand and follow all standard operating procedures.
- Define, implement, and improve GTI’s Quality Management System including development of process and product testing to ensure quality standards are met and oversee determination of finished product disposition.
- Partner with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant quality system.
- Implement and maintain sanitation and quality control practices that ensure the safety and quality of cannabis including purity and consistency.
- Implement HACCP, allergen, and sanitization management programs.
- Review and approve decisions about whether to investigate a cannabis product complaint and review and approve the findings and follow-up action of any investigation performed.
- Perform or oversee routine audits of compliance processes to assure accuracy and thoroughness of completion.
- Prepare site for compliance readiness for any external inspections. Analyzes facility trends in survey deficient practice to assess potential areas of continued non-compliance.
- Act as site lead in supporting any external inspections.
- Investigate and resolve compliance concerns, issues, or violations.
- Responsible for designated product release and product safety person.
- Establish and publish monthly metrics focused on facility’s current QA/QC progress.
- Responsible for site quality management review, conducting periodic reviews and escalating key issues to GTI leadership team.
- Routinely reviews monthly Corporate QA/QC documentation and assures that all areas of concern are addressed appropriately according to corporate policy and regulatory standards.
- Manage, train and develop QA/QC employees to perform in a proficient manner, providing motivation through personal example and interpersonal skills to create a cohesive unit.
- Promote awareness and responsibility through training and regular communication throughout the facility.
- Establish employee goals, monitor employee performance, and provide regular 1x1 performance feedback to help the employee succeed. Foster a high-performance culture through active leadership and create a strong sense of accountability within the department.
- Minimum 7+ years of QA/QC experience in a regulated production organization. FDA cGMP competency in 21 CFR Part 111 & 117. Cannabis experience is a plus.
- Bachelors Degree in Food Science, Chemistry, Engineering or similar required
- 3+ years of progressive leadership responsibility with a proven track record of building and developing QA/QC processes and systems
- Minimum of 3 years of regulatory compliance management including interfacing with regulators and inspectors
- Strong ability to effectively present information and responds to questions from senior management, function heads, managers, supervisors and all levels of employees
- Highly collaborative influencer who is an effective communicator and relation builder/networker
- SQF, ISO, GMP, ASQ, HACCP or similar certification experience preferred
- Experience in the development of a comprehensive QMS in a start-up or rapidly growing dynamic business environment
- Ability to deliver specific organizational goals and effectively develop, grow and manage a team to achieve objectives
- Track record of engaging teams and creating a collaborative QA/QC culture
- QMS auditor or similar certification a plus
- Thorough knowledge on the use of quality tools
- Experience in statistical and analytical problem solving
- Unassailable integrity and ethics
- Must have a solid understanding of the Medical Marijuana laws, rules and regulations and passion to further their understanding and knowledge of the industry and the laws
- Must pass any and all required background checks
- Must be and remain compliant with all legal or company regulations for working in the industry
- Must possess valid driver’s license
- Must be a minimum of 21 years of age
- Must be approved by state badging agency to work in cannabis industry