Regional Quality Manager

Location: McKeesport, PA

View cannabis job requirements in Pennsylvania
Job Posted:
Aug 22, 2024
Company:
Trulieve

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)

About Trulieve