Director, Quality Assurance and Control
Job Details
Management
GenCanna - Winchester, KY
Full Time
Description

Since helping to create this industry in 2014, GenCanna remains the single-source, full-service provider for premium hemp-derived CBD and other best-in-class cannabinoids.  Located just outside of Lexington, Kentucky, GenCanna offers a broad and innovative variety of custom formulations, value-added products, and bulk ingredients to meet diverse customer needs, including industry-leading flavored oil drops, water-soluble liquids and powders, and high-quality distillates.

Position Summary

The Director, Quality Assurance and Control (“DQ”) is responsible for managing GenCanna’s Quality, Compliance, and Environmental Health and Safety departments.  The DQ establishes and implements quality programs, procedures, and controls that ensure conformance with cGMPs, government, and industry standards.  The DQ is responsible for maintaining QA, QC, and compliance continuous improvement activities, and the documentation of them. 

As a member of the company’s customer acquisition and customer service teams, the DQ must be experienced in working collaboratively with customer product development personnel and address questions regarding formulations, testing methodologies, and expected product attributes.  The DQ must be able to articulate and present well-thought-out information in customer and company-facing meetings.

Essential Duties and Responsibilities

  • Develop and implement best practices for quality systems activities by working with peers from functional areas to implement continuous improvement programs
  • Ensure successful annual third-party audits: Brand Reputation through Compliance Global Standard (“BRCGS"); Current Good Manufacturing Practices for Human and Animal Food and Food Safety Modernization Act (“cGMP & FSMA”); Dietary Supplement Manufacturing Requirements; and Kosher certification, as well as additional accreditations as required by management
  • Develop a First Line of Defense (“FLOD”) to identify and remediate process gaps
  • Maintain quality and food safety accreditations against the above standards; ensure production targets and final products are released on-time and on-budget
  • Lead Quality Management Reviews, customer audits, and regulatory agency audits
  • Lead companywide quality mindset and culture of excellence
  • Lead QA/QC compliance engagement with federal, state, and local regulatory bodies (FDA, USDA, EPA, OSHA, departments of health) as well as UK and EU regulatory agencies
  • Maintain an working knowledge of industry requirements, regulations, and best practices
  • Develop strong relationships with customers and vendor-partners to ensure the design, supply, and maintenance of quality products and practices
  • Prepare product and process quality reports by collecting, analyzing, and summarizing information and trends
  • Manage document control program; write new SOPs, review and edit existing SOPs while maintaining traceability and accountability in document management
  • Manage customer specification and customer case management programs
  • Manage staff and carry-out employee management and supervisory responsibilities
Qualifications
  • Bachelor’s degree in a life sciences discipline; prefer Master’s degree; PCQI Certified
  • Minimum 10 years management experience in a regulated environment
  • Minimum five years of Quality management positions in biotech, pharmaceutical, dietary supplement, or food manufacturing industries
  • Experience working with CMO and contract laboratories
  • Experience working with analytical chemists, interpretation of results, familiarity with UPLC/MS, ICP, GCMS, and other industry-standard analytical techniques
  • Ability to manage tasks, deadlines, people, and extensive records
  • Must possess a good sense of judgment, commercial and solutions-oriented
  • Ability to develop, measure, and track KPIs
  • Ability to read/audit complex technical data/procedures to determine compliance with existing policies, processes, and procedures
  • Knowledgeable on departmental SOPs, understands equipment operations and equipment qualification protocols/troubleshooting; familiar with analytical instrumentation software
  • Detailed knowledge of process flow, including rejection, release, and reprocessing criteria
  • Demonstrated precision, accuracy, and thoroughness
  • Must be able to identify and correct errors, define and resolve problems, collect data, establish facts, and draw valid conclusions through RCA and corrective action procedures
  • Working knowledge of MS Office, quality, and laboratory management information systems

Professional Qualifications

Collaboration

With individuals of all levels, departments, and backgrounds, internal and external to the company.  Everyone’s participation is important to your and our success

Commitment

Giving 100% effort 100% of the time

Communication

Effective listener, speaker, and writer

Integrity

Always doing the right thing, regardless of who is or is not watching

Personal Presentation

Dress business casual for the office environment and when meeting customers directly and virtually

Respect

For yourself, co-workers, our customers, and vendor-partners

Time Management

Organize, prioritize, and execute multiple tasks in a fast-paced environment

Timeliness

Both in reporting to work and meetings and executing assigned task

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