Quality Assurance Manager

About Kutol Products Company

Kutol Products Company, a prominent name in hand hygiene and skin care, is dedicated to delivering high-quality products. With over a century of experience and headquartered at a LEED® Silver Certified, FDA-registered facility, Kutol is positioned for significant growth in the US and Canadian markets.

Role Overview

We are seeking a seasoned Quality Assurance Manager to lead QA efforts in our OTC drug and cosmetic manufacturing operations. This role demands a focus on regulatory compliance, continuous quality enhancements, and strong leadership to drive operational excellence within our quality systems.

Key Responsibilities

• Lead and mentor the QA Team comprising QA Technicians, Specialists, and Incoming Inspection personnel.
• Oversee the Quality Management System, managing deviations, CAPAs, change and document control, along with audit coordination.
• Ensure readiness for regulatory inspections including FDA, Health Canada, as well as customer, supplier, and internal audits.
• Conduct thorough investigations, root cause analysis, and verify effectiveness of corrective actions for deviations, nonconformances, OOS/OOT results, and customer complaints.
• Maintain oversight of product quality and related documentation such as SOPs, specifications, master manufacturing records, and validation protocols.
• Support microbiological risk management activities including environment monitoring, water system oversight, preservation strategies, and microbial risk assessments.
• Manage supplier quality by facilitating qualification, monitoring performance, conducting audits, and managing quality agreements.
• Participate in validation and change management processes ensuring quality oversight across equipment, process, cleaning, and method validations.
• Track and analyze quality metrics, identify trends, and lead initiatives targeting systemic improvements.

Candidate Requirements

• A bachelor’s degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, Engineering, or a similar scientific discipline.
• Minimum 5 years experience in Quality Assurance within a regulated manufacturing environment.
• At least 3 years in a leadership or supervisory role.
• In-depth knowledge of cGMP regulations, FDA regulatory mandates, and OTC drug manufacturing processes.
• Expertise in managing Quality Management Systems, investigation and CAPA workflows.
• Experience leading audits, handling inspections, and interacting with regulatory bodies.
• Superior problem-solving, communication, and leadership capabilities.

Benefits

Kutol offers a competitive salary coupled with an extensive benefits package that includes medical, dental, vision coverage, paid time off, and more. Employees benefit from a profit-sharing culture that fosters collective success annually.