Director of Quality (East Haven)

Head of Quality & Regulatory Affairs

Company : DCL Products, LLC

Location : East Haven, CT 06512

Reports to : CEO / COO

Employment Type : Full-time, On-site

Position Summary

DCL Products, LLC along with its wholly owned subsidiaries Milbar Labs, Inc. and Dermatologic Cosmetic Laboratories is seeking an experienced Head of Quality & Regulatory Affairs to lead all aspects of quality, compliance, and regulatory oversight at our FDA-registered, cGMP-certified contract manufacturing facility specializing in beauty, skin care, and hair care products. This leader will ensure adherence to FDA regulations, current Good Manufacturing Practices (cGMP), customer quality standards, and industry best practices while fostering a strong culture of quality throughout the organization.

Key Responsibilities

Quality Management & Compliance

Develop, implement, and maintain the Quality Management System (QMS) in alignment with FDA and cGMP requirements.

Oversee all aspects of product quality, including raw material qualification, in-process controls, finished product release, and post-market surveillance.

Lead internal and external audits; ensure timely remediation of findings and continuous improvement of compliance programs.

Monitor changes in FDA regulations and other applicable global regulatory requirements; update company policies and procedures accordingly.

Regulatory Affairs

Act as the primary liaison with FDA and other regulatory authorities, ensuring all required documentation, registrations, and facility filings are complete and up to date.

Oversee product compliance, including label reviews, claims substantiation, and regulatory submissions as applicable.

Provide regulatory guidance to R&D;, manufacturing, and client services to ensure product development and commercialization meet compliance standards.

Testing & Validation

Oversee stability testing programs, including protocol development, sample management, data review, and reporting.

Ensure appropriate testing of raw materials, intermediates, and finished products in compliance with cGMP standards.

Approve product specifications, methods validation, and analytical testing procedures.

Leadership & Cross-Functional Collaboration

Lead, mentor, and develop the Quality and Regulatory Affairs team to foster a culture of excellence and accountability.

Collaborate with Operations, R&D;, Supply Chain, and Client Services to ensure quality standards are

integrated across all functions.

Provide training and guidance to employees at all levels on FDA regulations, cGMP, and quality expectations.

Qualifications

Bachelors degree in Chemistry, Biology, Pharmaceutical Sciences, or related field (advanced degree

preferred).

10+ years of experience in Quality Assurance, Quality Control, and Regulatory Affairs, preferably within cosmetics, personal care, or pharmaceutical manufacturing.

Strong working knowledge of FDA regulations, cGMP, ISO standards, and ICH stability guidelines.

Experience leading FDA inspections and customer audits.

Proven success in building and managing high-performing quality and regulatory teams.

Excellent communication, leadership, and problem-solving skills.

Compensation & Benefits

Competitive salary

Comprehensive health and welfare benefits package

401(k) retirement plan

3 weeks paid vacation

11 paid holidays

Why Join Us

This is a high-impact leadership role at an FDA-regulated contract manufacturer with a reputation for excellence in beauty, skin, and hair care products. Youll have the opportunity to directly shape quality systems, regulatory compliance, and company growth while working in a collaborative, entrepreneurial environment.