Of our ten core values, the first is “… exceed our customer’s expectations.” This role, is the foundational cornerstone for achieving that. Overseeing the Quality Management System, ensuring that the company as a whole is compliant with ISO 13485:2016, FDA and GMP regulations. Collaborating with the Executive Management Team, and the Mid-Level Management team to develop new and better processes for meeting high quality standards. This position is great for someone who enjoys finding creative solutions and has fun in an exciting, ground-breaking and dynamic working environment.

The Director/ VP of Quality reports to the President of the Company and is responsible for overseeing and coordinating the quality department. Develops, interprets and implements quality policies, manages quality systems, and facilitates compliance inspections. Manages QA & QC operations to support the GMP manufacturing, testing and release of finished product under FDA standards and internal procedures. The Director of Quality is also responsible for conducting investigations into GMP-related issues, management of the QA change control process, SOP preparation/revisions, and GMP training programs.

• Oversee the internal and external audit program, which includes focus on cGMP compliance, regulatory agency inspection readiness, and for-cause inspections.
• Recommend systems for audit; write audit plans, coordinate scheduling, conduct and write reports to close audits. Follow-up on corrective actions.
• Ensure proper coordination of customer-initiated audits and mock regulatory inspections, and manage regulatory facility inspections.
• Manage documentation, reporting, and closure of compliance issues.
• Conduct trend analysis of audit results, and provide Executive management with initial root cause analysis.
• Review GMP quality metrics. Analyze data relating to process validations, process controls, and continuous process improvement efforts. Coordinate the necessary quality adjustments.
• Review relevant GMP documents for compliance to company SOPs, quality systems, and regulatory requirements.
• Oversee the following investigations: nonconforming product, customer complaint, laboratory out-of-specification, and corrective and preventive action.
• Ensure all investigations are performed and closed in a timely fashion. Monitor and report adverse events.
• Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies.
• Participate in or lead teams for special projects as assigned.
• Develop and work with staff to implement quality process controls relating to all areas of operation, including the following systems: quality, facilities and equipment, materials management, production, packaging, and labeling.
• Prepare and conduct the Quality Management Review meetings with senior management.
• Advises executive management on external environment and strategic compliance trend impacting our business.
• Manage company-wide training initiatives and document control systems.
• Additional tasks and project work as required

• Bachelor’s degree in Chemistry, Biochemistry or a Biological Science or equivalent experience preferred
• Ten years experience in industry as a minimum preferred
• Office and Laboratory work experience preferred
• Functional working knowledge of requirements for ISO 13485:2016, 21 CFR 820 and other applicable regulations