Cresco Labs is seeking a Quality Management System Director to join our corporate operations team at our Chicago headquarters. As our QMS Director, you will be responsible for implementation, execution, and maintenance of our QMS. As well as regulating, controlling and improving the quality of all processes throughout Cresco. The ideal candidate must possess a strong attention to detail and experience working within a highly regulated industry.
CORE JOB DUTIES:
- Oversee creation and maintenance of Quality Management System (QMS) and training infrastructure for a medical cannabis start-up company
- Create and/or update QMS-related programs such as CAPA, customer complaint handling, adverse event reporting, Quality Control measures, etc. according to state regulations
- Work with Compliance functions to ensure QMS activities comply with state regulations and are adhered to
- Develop and manage QMS operational processes and supporting SOPs, training, forms/templates
- Responsible for implementation/rollout of new programs as well as changes to existing processes across departments/functions
- Responsible for change management and document management, including product design changes.
- Manage training/onboarding program and use of Learning Management System
- Support audit and internal monitoring, as requested
- Review operational metrics and KPIs to evaluate health of QMS programs and identify areas for improvement
- Manage QMS personnel
- Will interface with all functions within the company: cultivation, laboratory, kitchen, packaging, order fulfillment, compliance, sales, engineering, IT/systems
- Assign SOPs/training materials to respective audiences in Learning Management System
- Work with subject matter experts to develop training self-assessments/evaluations during new employee on-boarding and for annual refresher training
REQUIRED EXPERIENCE, EDUCATION AND SKILLS:
- Bachelor’s Degree preferred, 5-10 years’ experience
- Prior experience in highly regulated industry. Highly desirable: healthcare, medical devices, pharmaceutical, cannabis.
- Prior experience in compliance, ethics, legal, or quality function. Subject matter expert in multiple quality-related concepts: CAPA, AE reporting, AQLs, QC checks, product stability testing, customer compliant handling, product investigations and withdrawal/recall procedures, change management, document management, etc.
- Ability to design and implement new processes, including operational workflow, writings new SOPs, designing forms/templates to support process.
- Experience with training/onboarding programs and tools/systems
- Excellent written and verbal communication skills
- Detail-oriented
- Prior management experience; will have direct reports
- Quick learner – grasps essence quickly and uses information learned to apply elsewhere
- Deals well with ambiguity and gray areas; strikes a balance between business and compliance needs
- Understands the large-scale ideas and can deliver on tactical execution
- Minimal travel required
ADDITIONAL REQUIREMENTS:
- Must be 21 years of age or older to apply
- State and Federal Background check
- No criminal history
Job Type: Full-time
Experience: