Director, Site Quality

Cannabis At Work - Atholville, NB (30+ days ago)

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The Director, Site Quality will be the Head of Quality and a key member of the Site Leadership Team with dotted line reporting to the Facility Director. In this role you will be a critical leader of the Quality function and will drive improvement activities including the development and maintenance of the Quality Management System (QMS) and comprehensive quality metrics. You will undertake the broadest possible involvement in every aspect of cannabis production and testing, and facility operations related to the quality of products produced. The incumbent is responsible for the release of all products and to assure they have been produced from approved processes in conformance to all applicable regulatory requirements and Company policies

The position will partner with the manufacturing and R&D organizations and support teams to make recommendations, set goals and implement solutions for process improvements. Another key component of your role will be leveraging your ability to effectively lead a team and facilitate the learning and development opportunities for your and the greater organization.

Core Competencies:

  • Demonstrated subject matter expertise and knowledge of theories, principles and concepts of the Pharmaceutical Quality System
  • Knowledge of Quality Risk Management
  • Experience leading regulatory inspections and audits
  • Extensive knowledge of EU/US/ICH GMP regulations and related standards
  • Proven ability to lead change through an organization

Duties and Responsibilities:

  • Manages and coordinates all Quality Assurance and Quality related activities
  • Ensures compliance of QMS with GxP regulations, including Health Canada, EU and FDA
  • Develops and implements programs to establish and maintain quality standards of existing products, as well as developing programs to focus employees on quality improvement
  • Implements policies, procedures and methods to check product, material, components and/or quality and improve same
  • Provides Quality leadership and direction to support business operations and development of the site quality strategy
  • Provides focus on the quality status and performance of the facility by instilling a culture of quality and continuous improvement
  • Assures the implementation and alignment of the QMS, and compliance to the pertinent global regulations
  • Accountable for the release of products and to assure they have been produced from approved processes in conformance to all applicable regulatory requirements and Company policies
  • Ensures that all necessary testing is carried out and the associated records evaluated, in accordance with approved specifications, sampling instructions, test methods and other relevant procedures
  • Plans, directs, and coordinates all Quality operation activities to assure production plans are met
  • Responsible for day-to-day management, setting objectives, coaching and developing employees, and performance appraisal
  • Defines team organization and roles and responsibilities
  • Drives important negotiations and influences stakeholders internally
  • Supports interactions with authorities by the Compliance team
  • Approve signatory for major changes and NPI reviews
  • Lead and manage critical quality incidents, interaction with authorities with the support of the Compliance team and supports quality operations
  • Perform gap assessments and lead the site implementation of corporate Quality policies
  • Participate in the recruitment and development of Quality staff, ensuring all team members have appropriate goals and objectives set

Qualifications:

  • Bachelor's degree in a Science/Technical discipline
  • 8+ years of hands-on experience in Quality with managerial experience
  • A minimum of 3 years at manager level or higher leading 2 or more functional groups in a life science, GMP regulated industry
  • Proven experience developing teams
  • Experience with common continuous improvement tools (e.g., Six Sigma)
  • Excellent written and verbal communication/presentation skills and organizational skills
  • Logical in thought and detailed focused
  • Analytical approach to problem solving and decision making
  • Excellent negotiation skills
  • Demonstrated leadership and management experience working with cross functional teams on complex projects
  • Experience in a startup facility or with technology transfer

Job Type: Full-time