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
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