Quality Manager

Quality Manager – Dietary Supplements & OTC Manufacturing

Location: Long Island, NY (Onsite)

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

What Our Client Offers You:

• $135,000 – $145,000 base salary, with flexibility above range for exceptional candidates
• 10% annual bonus opportunity
• Comprehensive benefits package
• PTO, Paid sick time, holidays
• 401k with match

What You’ll Do:
As the Quality Manager, you will provide hands-on leadership for quality assurance, regulatory compliance, and continuous improvement. This position is responsible for developing, implementing, and maintaining the Quality Management System (QMS), ensuring compliance with FDA regulations, and partnering with cross-functional leadership.

Key responsibilities include:

• Leading and maintaining the facility’s Quality Management System (QMS) to ensure regulatory compliance and inspection readiness
• Ensuring compliance with FDA 21 CFR Part 111 and 21 CFR Parts 210/211 requirements, including applicable OTC monographs
• Leading FDA inspections, customer audits, and third-party audits, including responses to regulatory observations
• Overseeing CAPA, deviations, investigations, change control, complaint management, and document control
• Managing product disposition and release decisions for raw materials, packaging components, in-process materials, and finished products
• Reviewing and approving SOPs, specifications, Master Manufacturing Records, and other controlled quality documents
• Overseeing product recalls, adverse event reporting, and required FDA registrations and product listings
• Establishing quality performance metrics and driving continuous improvement initiatives
• Partnering with Operations, R&D, and Supply Chain to support new product development, regulatory compliance, and customer requirements

Qualifications You Have:

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Food Science, or a related scientific discipline
• 5+ years of quality experience in GMP-regulated manufacturing, preferably within dietary supplements and/or OTC pharmaceuticals
• Demonstrated experience leading FDA inspections, customer audits, and regulatory compliance activities
• Strong knowledge of Quality Management Systems, CAPA, deviations, change control, and GMP documentation
• Understanding of OTC monograph requirements, product labeling, and regulatory compliance
• Experience developing, implementing, and improving quality processes within a regulated manufacturing environment
• Strong leadership, decision-making, and communication skills with the ability to work across multiple departments

How to Apply:
If you like what you see here, please Apply Now to submit your resume. A real, live Kinsa Group Recruiter, Stephanie Savage, will review your information and get in touch if we think you’re a great fit. But, if you’d rather, please drop an email to stephanies@kinsa.com.

Recruiter Information:
Stephanie Savage
stephanies@kinsa.com