Director of GMP Manufacturing

Company: N8 Essentials
Location: Olathe
Posted on: May 9, 2020

Job Description:

N8 Essentials, a family owned health and wellness product manufacturer, is looking for a Director of GMP Manufacturing and Regulatory Compliance in Olathe Kansas. N8 Essentials was founded on the principles of using natural and organic products to improve the lives of families. N8 Essentials is experience significant growth and as such expanding our team to not only handle today's growth but future growth as well. We are a business that considers our team family members. If you would like to get away from the corporate hustle and bustle and join our family, send us your CV for immediate consideration. MISSION AND KEY ROLE FOCUSES Oversight of the Quality Management Plan and Manufacturing Operations FDA and Regulatory compliance experience, specifically a high level of knowledge regarding compliance with CFR Parts 111, 117, and 211. Scientific thought leader on projects and manufacturing. Provides manufacturing support including troubleshooting, problem solving, and technical assistance. Oversight of GMP manufacturing operations and maintenance of certifications. GMP auditing certification preferred. Lab and Production Maintenance and Management Ensures safety of all personnel and/or visitors, and assists in maintenance of safety systems. Development and execution of SOPs for processes in quality control laboratory. Leads in development of training plans and training of team members. Leads in development and maintenance of training curricula. Identifies equipment and tools needed for QA/QC/Production. Provides input for performance reviews and compensation approvals. Assists with root cause analysis of deviations, determining CAPA action items, and review of final related documentation. Oversight of change control. Regulatory activities and advisement. QA/QC management activities. Audits and Inspections. Develops assigned direct reports. Performs business and strategic planning for area of responsibility and aligns with company objectives. KEY SKILLS, ATTRIBUTES, AND QUALIFICATIONS MS or PhD Chemistry preferred, with 10+ years cumulative experience, ideally in a cosmetic, dietary supplements and/or pharmaceutical GMP manufacturing environment. Customer focus, results driven and can-do mentality: work with high motivation to deliver results. Strong people skills, team leadership, working with peers, and reporting to C-Suite; strong communications skills. Self-starter/time-management: Able to initiate projects and bring new ideas into the organization. Capable of self-management of multiple project/tasks. Team-player: Builds on expertise of team and can see the "big picture" to drive optimal results. Change management skills. Problem solving skills, understanding of experimental design, and statistical analysis. External network: Able to build and maintain network with customers, Universities, Research Institutes, consultants, and external labs. Project oversight. Aligns on resources with C-Suite. Eligibility Requirements Must be legally authorized to work in the United States without restriction Must be 18 years of age or older N8 is an equal opportunity employer. It prohibits discrimination based on age, color, disability, national origin, race, religion, sex, veteran status and any other legally protected class in accordance with applicable federal, state, and local laws Employment Type: Full Time Years Experience: 10 - 15 years Salary: 110000.00 Annual Bonus/Commission: No

Keywords: N8 Essentials, Olathe , Director of GMP Manufacturing, Executive , Olathe, Kansas