Quality Assurance Manager
About The Position
Kutol Products Company, a recognized leader in hand hygiene and skin care solutions, is seeking an experienced Quality Assurance Manager to lead our QA operations and play a critical role in advancing our quality culture. This is an exciting opportunity for a quality professional who is passionate about regulatory compliance, continuous improvement, and building strong quality systems that support operational excellence. As the Quality Assurance Manager, you will lead QA activities for our OTC drug and cosmetic manufacturing operations, ensuring compliance with current Good Manufacturing Practices (cGMP), FDA regulations, Health Canada requirements, and internal quality standards. You will serve as a key leader in strengthening our Quality Management System (QMS), driving investigation and CAPA effectiveness, supporting audit readiness, and partnering cross-functionally to ensure product quality and regulatory compliance. If you thrive in a fast-paced manufacturing environment and enjoy leading teams, solving complex quality challenges, and driving continuous improvement initiatives, we'd love to hear from you.
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.
Responsibilities
- 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
Benefits
- medical
- dental
- vision
- paid time off
- profit sharing
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What This Job Offers
Job Type
Full-time
Career Level
Manager
