Director, QA

Director of Quality Assurance
Greater Boston Area | Onsite
Pharmaceutical Manufacturing
Full-Time | Site Leadership Role

A pharmaceutical manufacturing organization is seeking a Director of Quality Assurance to lead site-wide quality operations and oversee all aspects of the Quality Assurance function. This is a highly visible leadership role responsible for quality systems, batch release, compliance, audits, investigations, and QA team leadership.

This opportunity is best suited for a hands-on QA leader who enjoys being embedded in manufacturing operations and making real-time quality decisions in a GMP-regulated environment.

Key Responsibilities

Quality Operations Leadership

• Lead and develop the Quality Assurance organization
• Provide oversight of daily QA operations across manufacturing and quality systems
• Ensure compliance with cGMP regulations and internal quality standards
• Serve as the primary QA representative for site leadership

Batch Release & Product Disposition

• Review and approve raw material, in-process, and finished product release activities
• Oversee batch record review and product disposition decisions
• Ensure manufacturing records and associated documentation meet quality requirements

Quality Systems

• Own and manage the Quality Management System (QMS)
• Lead deviation investigations, CAPAs, change controls, non-conformances, and complaint activities
• Drive continuous improvement initiatives across quality processes
• Maintain and improve SOPs, specifications, protocols, and quality documentation

Audit & Inspection Readiness

• Lead internal audit programs and vendor quality audits
• Act as primary quality contact during regulatory inspections and customer audits
• Ensure ongoing inspection readiness across the site
• Support implementation of corrective actions resulting from audits and inspections

Cross-Functional Support

• Partner closely with Manufacturing, QC, Validation, Engineering, and Regulatory teams
• Provide QA oversight for facility, equipment, and process changes
• Support training, process improvements, and operational excellence initiatives

Qualifications

• BS degree in Biology, Chemistry, Pharmacy, or related scientific discipline
• 10+ years of Quality Assurance experience within pharmaceutical manufacturing
• Previous leadership experience managing QA teams
• Strong background in batch release, product disposition, deviations, CAPAs, investigations, and change control
• Deep understanding of cGMP requirements and FDA regulations
• Experience supporting regulatory inspections and audit activities
• Comfortable operating in a hands-on manufacturing environment

Ideal Background

• Director, Associate Director, Senior Manager, or Manager-level QA professionals
• Site-based pharmaceutical manufacturing experience
• Experience leading QA support for commercial manufacturing operations
• Strong people leadership, decision-making, and problem-solving capabilities