Director of Quality Systems & Compliance - Barrington James : Job Details

Overview

Director of Quality Systems & Compliance – Chicago (Hybrid)

We're partnered with a fast-growing pharmaceutical company on a retained search. They're committed to delivering high-quality, innovative healthcare solutions with expertise across sterile, topical, and combination product platforms. This is a leadership role focused on building and strengthening quality systems and ensuring quality supply in a mission-driven organization.

Lead with impact by owning and evolving the Quality Management System (QMS) across internal operations and external partners, ensuring compliance with global regulatory standards and driving operational excellence for pharmaceutical and medical device programs.

Responsibilities

• Lead the design, implementation, and continuous improvement of the QMS to meet FDA and global regulatory expectations
• Establish robust quality processes to enhance efficiency, reduce risk, and ensure inspection readiness
• Oversee the implementation and management of an electronic QMS (e.g., Qualio, DocuSign, TraceLink)
• Direct internal audit planning, execution, and CAPA management
• Build and lead the Supplier Quality team and processes
• Serve as the company's lead during regulatory inspections and audit readiness efforts
• Manage document control for SOPs, specifications, batch records, and protocols
• Ensure timely initiation and closure of quality records, deviations, and change controls
• Oversee corporate GMP training and evaluate program effectiveness
• Facilitate Management Review meetings and Annual Product Quality Reviews (APQRs)

Qualifications

• Bachelor's degree in a life sciences field (Chemistry, Pharmaceutical Sciences); advanced degree a plus
• 9+ years of experience in FDA-regulated pharmaceutical or biotech environments
• Strong working knowledge of cGMPs, 21 CFR Parts 11, 210, 211, 820, and international standards (ISO 13485, ICH, WHO, PIC/S)
• Hands-on experience with combination products, sterile manufacturing, and contract manufacturing oversight preferred
• Proven leadership in regulatory inspection preparedness and eQMS implementation
• Strong communicator and collaborator who thrives in fast-paced, high-growth settings

Additional details

• Seniority level: Director
• Employment type: Full-time
• Job function: Science, Accounting/Auditing, and Manufacturing
• Industries: Pharmaceutical Manufacturing and Biotechnology Research

Apply

Apply today to learn more, or reach out directly to [email protected]