Quality Director

Quality Director – North America

Location:

Long Island, NY (Onsite)

About Our Client:
Our client is a growing manufacturer of dietary supplements and over-the-counter (OTC) pharmaceutical products, serving leading consumer brands. With multiple manufacturing operations, the company is focused on strengthening quality systems, regulatory compliance, and operational excellence across its North American facilities.

What Our Client Offers You:

• $180,000 – $200,000 base salary, with flexibility above range for exceptional candidates
• 20% annual bonus opportunity
• Comprehensive benefits package
• PTO, Paid sick time, holidays
• 401k with match

What You'll Do:

As the Quality Director – North America, you will provide strategic and hands-on leadership for quality assurance, quality control, and regulatory compliance across multiple manufacturing facilities. This position is responsible for developing and maintaining a Quality Management System (QMS), ensuring compliance with FDA regulations, and partnering with senior leadership to establish a strong culture of quality, accountability, and operational excellence.

Key responsibilities include:

• Leading Quality Assurance, Quality Control, and Quality Systems functions across multiple manufacturing facilities
• Ensuring compliance with FDA 21 CFR Part 111 and 21 CFR Parts 210/211 requirements
• Leading FDA inspections, regulatory audits, and customer audits, including responses to FDA Form 483 observations
• Overseeing CAPA, deviations, investigations, change control, validation, and document management
• Driving inspection readiness, regulatory compliance, and continuous improvement initiatives
• Managing supplier quality, qualification programs, and product release processes
• Overseeing laboratory operations, environmental monitoring, and stability programs
• Establishing quality performance metrics and implementing corrective actions to improve results
• Developing and mentoring site quality leaders while building a strong culture of quality and accountability

Qualifications You Have:

• Bachelor’s degree in Chemistry, Microbiology, Biology, Pharmacy, Food Science, Engineering, or a related scientific discipline
• 12+ years of progressive quality experience in FDA-regulated manufacturing, dietary supplement and OTC drug industry experience preferred
• 5+ years of senior-level quality leadership experience
• Demonstrated experience leading Quality functions across multiple manufacturing sites
• Direct, hands-on experience with both FDA 21 CFR Part 111 and 21 CFR Parts 210/211
• Proven success leading FDA inspections, customer audits, and regulatory responses, including FDA Form 483 observations
• Strong knowledge of Quality Management Systems, CAPA, validation, data integrity, and supplier qualification
• Experience developing and implementing standardized quality processes across manufacturing operations
• Ability to travel periodically to other manufacturing facilities and supplier locations