Director of Quality Assurance & Regulatory Affairs

Leslie's•Cahokia, IL

About The Position

The Director of Quality Assurance & Regulatory Affairs provides strategic leadership for Stellar Manufacturing's quality management systems, regulatory compliance, and product stewardship programs. This role is responsible for ensuring products consistently meet customer expectations, regulatory requirements, and industry standards while fostering a culture of quality, safety, operational excellence, and continuous improvement. Working cross-functionally with Production, Supply Chain, Procurement, Sales, R&D, and Executive Leadership, the Director oversees quality systems, regulatory strategy, laboratory operations, audits, customer quality, and risk management to support business growth and product integrity.

Requirements

Bachelor's degree in Chemistry, Chemical Engineering, Biology, Materials Science, or a related scientific field.
10+ years of progressive experience in Quality Assurance and Regulatory Affairs, preferably in chemical manufacturing.
5+ years of leadership experience managing quality organizations.
Strong knowledge of Quality Management Systems (QMS), regulatory compliance, and chemical manufacturing processes.
Experience leading customer, supplier, ISO, and regulatory audits.
Demonstrated success implementing continuous improvement methodologies such as Lean, Six Sigma, Root Cause Analysis, and CAPA.
Excellent leadership, communication, organizational, and problem-solving skills.
Proficiency with Microsoft Office and quality management systems.

Responsibilities

Lead the company's Quality Management System (QMS) and drive a culture of quality, safety, and continuous improvement.
Oversee Quality Assurance, Quality Control, Regulatory Affairs, and Product Stewardship functions.
Ensure compliance with all applicable federal, state, and industry regulations.
Develop quality strategies, policies, performance metrics, and continuous improvement initiatives.
Lead internal, customer, supplier, certification, and regulatory audits, ensuring ongoing audit readiness.
Oversee CAPA, root cause investigations, documentation control, and change management processes.
Direct Quality Control laboratory operations, including analytical testing, equipment calibration, and quality documentation.
Serve as the primary liaison with regulatory agencies, customers, and industry partners on quality and compliance matters.
Partner with Production, Supply Chain, Procurement, Sales, and Executive Leadership to support product quality, regulatory compliance, and new product commercialization.
Lead investigations and resolution of customer quality concerns and product-related issues.
Identify quality and regulatory risks and implement mitigation strategies, including product recalls when necessary.
Lead, coach, and develop Quality Assurance, Quality Control, and Regulatory Affairs teams while managing departmental goals, budgets, and resources.

Benefits

Comprehensive medical, pharmacy, dental, & vision plan options.
Health savings account (with enrollment in the high deductible health plan option).
Health & dependent care flexible spending accounts.
Company-paid basic life and AD&D insurance.
Voluntary supplemental life insurance.
Company-paid short-term disability and voluntary long-term disability insurance.
Pre-tax and Roth 401(k) with company match.
Paid vacation, sick, and bereavement leave.
Paid holidays, including a floating personal day.
Employee assistance and wellness programs.
Earned Wage access is available, allowing early access to a portion of your earned wages before payday.
Product discounts at Leslie’s Retail stores.