Director of Quality - Manufacturing - Glassboro, NJ

Director Quality Manufacturing

The key responsibilities for the Director of Quality will be :

• Develop and oversee execution of quality strategy aligned with company goals and regulatory requirements (e.g., ISO 9001, ISO 13485, FDA, cGMP).
• Lead and mentor the Quality Assurance, Quality Control, and Regulatory Affairs teams across multiple manufacturing sites.
• Drive continuous improvement initiatives across production and quality functions using lean, Six Sigma, and other data-driven methodologies.
• Ensure compliance with all applicable national and international standards and regulations related to life sciences and laboratory product manufacturing.
• Maintain and enhance the company's Quality Management System (QMS), including audits, CAPAs, document control, and training.
• Interface with customers and regulatory agencies during audits, inspections, and quality-related discussions.
• Establish, track, and report key quality performance metrics (e.g., customer complaints, returns, defects, audit findings).
• Collaborate with R&D, Manufacturing, Supply Chain, and Commercial teams to ensure product quality from design through delivery.
• Champion a strong quality culture across all levels of the organization.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The successful Director of Quality will have the following :

My client can offer the following for the Director of Quality :