Company & Role Overview
Summary
"Trulieve Grows One Patient at a Time"
Requisition ID:
Remote Work Available:
Job Title:
Department:
Reports to:
Location: Must live in Northeast United States,
ROLE SUMMARY:
KEY DUTIES AND RESPONSIBILITIES:
- Responsible for management, development, and mentoring of all site QA managers and QA
- personnel in the Region of coverage
- Serve as escalation point for site quality issues with respect to the following activities:
- Finished product sampling and inspection
- Product complaints and investigations
- Corrective and Preventive actions (CAPA)
- Non-conformances and deviations
- Product withdrawals, recalls
- Internal and external audits.
- Ensures that KPI targets are met at each site and across the region.
- Holds QA Managers accountable for site Quality performance and deliverables.
- Working with the National Director of Quality to design and implement site manager employee development plans and key position succession planning.
- Review and approve critical customer complaints and product investigations, helping to assess risk, identify root cause, CAPA plans, and implementing solutions with business partners.
- Work with Quality subject matter experts (SMEs) to generate ideas for projects and process improvements.
- Ensure sites are utilizing approved controlled documents, completing training on-time. Discuss issues and concerns directly with operations management and senior leadership.
- Collaborate with operational functions to troubleshoot manufacturing and production defects, CAPA, and customer complaints. Provide advice with process improvements to eliminate errors and reduce risk.
- Consolidate technical information from operations and manufacturing personnel and prepares written investigation and CAPA reports in a timely manner which may be provided to state regulators. Discuss quality-related issues with state regulators, as needed.
- Monitor compliance to established current Good Manufacturing Practices (cGMPs), cGMP
- Product Safety and ISO Quality Management Standards.
- Maintain Hazard Analysis Critical Control Point (HACCP) documentation as required.
- Overall accountability for product, quarantine, destruction, rework, and withdrawal/recall.
- Conduct all duties in compliance with safety rules, applicable SOPs, and other applicable guidelines.
- Maintains internal and external audit readiness to applicable cGMP/GAP standards.
SKILLS AND QUALIFICATIONS:
- Experience in highly regulated industry: healthcare, medical devices, pharmaceutical, consumer packaged goods (food), cannabis, or tobacco.
- Experience overseeing and leading Quality functions
- Experience with product sampling, inspection procedures, customer complaints, product investigations, and CAPA
- Experience in regulatory agency audits and correspondence.
- Strong written and verbal communication skills, including writing executive summaries and communicating with senior level operations, quality management team, and regulatory agencies
- Detail-oriented
- Utilizes critical thinking to troubleshoot issues, work collaboratively with a team to brainstorm solutions, and implement improvement solutions
- Lead and manage personnel, including performance management, setting vision, priorities, etc.
- Demonstrates high sense of urgency and proactive thinking
- Prior Experience with a Quality Management System (QMS)
- Prior Experience with Continuous Improvement initiatives
- Experience with Good Agricultural Practices (GAP) is a plus
- Experience with ERP systems such as SAP is a plus
EDUCATION AND EXPIRIENCE:
- Bachelor's Degree Preferred
- 5+ years' experience in a quality role
ADDITIONAL REQUIREMENTS:
- Must be a minimum of 21 years of age (or a minimum of 18 years of age in CT, PA and WV).
- Must successfully complete a comprehensive background screening.
PHYSICAL REQUIREMENTS:
WORK SCHEDULE:
Nearest Major Market:
Working Environment
(No Information)