Key Areas of Responsibility Include:- Lead and develop the QA Team including QA Technicians, Specialists and Incoming Inspection
- Lead the Quality Management System with regard to deviations, CAPA's, change and document control, and audit management
- Ensure regulatory compliance and inspection readiness for FDA, Health Canada, customer, supplier and internal audits
- Lead complex investigations, root cause analysis and CAPA effectiveness involving deviations, nonconformances, OOS/OOT results and customer complaints
- Provide product quality and documentation oversight including SOP's, specs, master mfg records, validation protocols, etc.
- Support Microbiological risk management providing oversight for environment monitoring programs, water systems, preservation strategies, and micro risk assessments
- Manage supplier quality and quality risk by supporting supplier qualification and ongoing performance management, supplier audits and quality agreements
- Support validation and change management providing quality oversight for equipment, process, cleaning and method validations
- Monitor and report out metrics, analyze trends and identify/lead initiatives for systemic improvement
Requirements- Bachelor's degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, Engineering, or a related scientific field.
- 5+ years of Quality Assurance experience in a regulated manufacturing environment.
- 3+ years of leadership or supervisory experience.
- Strong working knowledge of:
- cGMP regulations
- FDA requirements
- OTC drug manufacturing
- Quality Management Systems
- Investigations and CAPA processes
- Experience leading audits, inspections, and regulatory interactions.
- Excellent problem-solving, communication, and leadership skills.
BenefitsCompetitive salary range with a comprehensive benefit package including medical, dental, vision, paid time off and more. Our shared fate culture has resulted in a strong track record of company-wide profit sharing, a goal that every Teammate works to achieve annually.
