National Director, Quality

  • Cannabis Jobs
  • Philadelphia, PA, USA
  • 24 Feb, 2021

Job Description

GET TO KNOW JUSHI We identify, evaluate, and acquire U.S.-based cannabis operations within each state to vertically integrate, produce, and distribute medical-grade cannabis formulations in the United States offering patients and customers premium, high-grade cannabis and related products. THE OPPORTUNITY The National Director, Quality will develop, manage, and lead the quality assurance function, working in partnership with sales, engineering, procurement, and operations, to ensure the highest possible quality outcomes for Jushi. The Director, Quality will assist in the development and implementation of an effective, robust quality management system (QMS) processes and methods in alignment with FDA CFR requirements, and will utilize metrics to improve quality processes and efficiency continually. Will be responsible for creating the company?s Quality System and will help to define, communicate, and implement the company?s quality strategy and vision. + Manage and direct a team of QA professionals in the development of Quality Management systems, ensure that both internal (Manufacturing) and external (Supplier) processes are conducted with consistency and control, and will promulgate a culture of excellence and compliance throughout the organization. + Regular travel to the different facilities and locations throughout the organization. + Participate in new GMP facility design, construction, and process implementation. + Develop, refine and educate team members on quality management program to ensure there is an in-depth understanding of program and individual responsibilities + Oversee GMP production operations, including establishing SOPs, training, and oversee operations for quality controls and GMP compliance. + Perform regular internal and contract manufacturer audits, track trend quality metrics and KPIs. + Ensure improvement and alignment of the Quality Management Systems across locations + Provide advice with process improvements to eliminate errors and reduce risk. + Conduct all duties in compliance with safety rules, applicable SOPs, and other relevant guidelines. + Serve as an escalation point for corporate quality issues, including investigations, recalls, deviations, CAPA, Change controls, inspections, clearances, validation, and training. + Serve as a resource working with research staff in study design, data collection and analysis, reporting activities that support quality improvement interventions, transparency, compliance regulatory standards and provide performance monitoring. + Assure review and approval of batch record documentation, including validation protocols, master batch records, analytical test results, packaging, and labeling documentation. + Represent the Quality function during inspections by regulatory authorities and customers. EDUCATION & EXPERIENCE + Bachelor?s degree in Science or similar technical discipline is required. Master?s degree preferred. + 10+ years? experience in Quality Assurance and Regulatory Affairs. + Familiarity with 21 CFR 111, cGMP practices, DSHEA, FDA regulation, and audits + Extensive knowledge of cGMP requirements in dietary supplement or pharmaceutical manufacturing + The ability to travel 50-75% of the time. + Experience working in FDA-regulated industry. + Experience with FDA inspections and communication with regulators + Experience in budget management and managing scientific staff from a budgetary and personnel standpoint. + Proven ability to work effectively with cross-functional stakeholders in a complex/changing global environment. + Experience with all phases of the product development lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization a plus. OTHER DUTIES Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice Jushi is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. We offer benefit packages that may include: Medical, Dental, Vision, Life, Short, and Long Term Disability, Flexible Spending Accounts, Paid Time Off, Paid Holidays, and 401(k).