Director of Quality and Regulation ~ FDA, Pharmaceutical - Imagine Staffing Technology, An Imagine Company : Job Details

Job Title: Director of Quality and Regulation

Work Model: Onsite, Monday–Friday, Flexible 8:00 AM – 5:00 PM

Location: Buffalo-Niagara Falls Area

Overview

We are seeking an experienced Director of Quality & Regulation to join the executive leadership team. This role will be responsible for developing and implementing the strategy, systems, and standards for the quality and regulatory function, ensuring compliance with all applicable legal and industry requirements. The successful candidate will collaborate with leadership peers across Manufacturing, Supply Chain, R&D, HR, and other key functions to drive quality excellence and ensure adherence to cGMP, FDA, EPA, OSHA, and other regulatory standards.

Responsibilities

• Provide leadership for the site's quality and regulatory function as part of the executive leadership team.
• Develop and oversee systems, policies, and standards to ensure compliance with cGMP, FDA, EPA, OSHA, and related requirements.
• Establish and maintain SOPs, internal audit programs, and training initiatives.
• Manage the Quality Laboratory and support Environmental Health & Safety compliance.
• Ensure adherence to customer quality requirements and implement corrective actions for any deviations.
• Oversee quality control and assurance systems, investigating failures and driving timely resolutions.
• Lead inspections of incoming goods (raw materials, components, finished goods) in compliance with agreed standards.
• Direct monthly site audits, reporting results to leadership and ensuring corrective actions are taken.
• Audit and manage suppliers to confirm compliance with established standards.
• Partner with Manufacturing and R&D to ensure product quality across all production batches.
• Serve as point of contact for 3rd party, government, and independent audits.
• Review and approve packaging labeling for compliance with regulations and substantiation requirements.
• Represent the company with professional organizations and industry groups.
• Lead, mentor, and develop staff across the quality and regulatory function, including direct and indirect reports.

Qualifications

• 10–15 years of experience in quality and regulatory functions within a manufacturing environment.
• In-depth knowledge of FDA cGMP regulations and ISO standards.
• Proven experience managing compliance with regulatory agencies.
• Expertise in OTC monographs, labeling, and claim substantiation.
• Strong communication skills with the ability to influence cross-functional teams.
• Demonstrated leadership in managing, training, and developing staff.

Employment type: Full-time

Industries: Pharmaceutical Manufacturing and Food and Beverage Manufacturing