Head of Quality Assurance

Position Overview

Our client, an innovative biopharmaceutical company based in Boston, is seeking a Head of Quality Assurance to lead the overall QA function and ensure the highest standards of GMP compliance, product quality, and operational excellence across development and commercial activities.

This individual will serve as the company’s senior QA leader, responsible for setting the quality vision, overseeing GxP compliance, building and developing quality teams, and partnering closely with Manufacturing, CMC, Technical Operations, Supply Chain, and Regulatory Affairs.

This is a high-impact, onsite leadership role ideal for a seasoned QA executive with strong GMP experience in biologics, advanced therapies, or other regulated modalities.

Key Responsibilities

Quality Leadership & Strategy

• Define, implement, and lead the company-wide Quality Assurance strategy in alignment with organizational goals and global regulatory expectations.
• Serve as the primary authority on QA standards, policies, and GxP compliance across all operations.
• Provide strategic oversight across GMP, Quality Systems, QA Operations, and Supplier Quality.

GMP Compliance & Quality Systems

• Ensure full compliance with FDA, EMA, ICH, and global regulatory guidelines.
• Oversee development, maintenance, and continuous improvement of the Quality Management System (QMS).
• Lead GMP oversight of manufacturing operations, batch record review, and product release activities.
• Manage deviation investigations, CAPAs, change controls, and quality risk management processes.

Manufacturing & Operational Quality

• Partner closely with internal and external manufacturing teams to ensure quality oversight throughout the product lifecycle.
• Support tech transfers, scale-up activities, comparability, and process validation from a QA perspective.
• Provide quality leadership for raw materials, suppliers, CMOs, and testing labs.

Regulatory & Inspection Readiness

• Act as a key interface with regulatory agencies on quality-related matters.
• Lead site inspection readiness activities and manage responses to regulatory findings.
• Provide QA input into regulatory submissions, including Module 3 and GxP documentation.

People Leadership & Organizational Development

• Lead, mentor, and build a high-performing QA team covering Quality Systems, QA Operations, Supplier Quality, and Quality Compliance.
• Establish clear expectations, training, and succession planning to support growth and scalability.
• Foster a culture of accountability, continuous improvement, and proactive quality thinking.

Qualifications

Education

• Bachelor’s degree required; advanced degree (M.S., Ph.D., Pharm.D.) in a life sciences discipline preferred.

Experience

• 12–18 years of progressive experience in Quality Assurance within the biopharmaceutical industry.
• 7 years in QA leadership roles managing teams and complex GxP operations.
• Strong background in GMP quality oversight, manufacturing operations, and QMS management.
• Experience working with biologics, cell & gene therapies, mRNA, or other complex modalities strongly preferred.
• Proven track record of inspection readiness and successful interactions with FDA, EMA, or other global authorities.
• Experience supporting clinical and/or commercial product quality.

Skills & Leadership Attributes

• Deep understanding of global GxP regulations and industry standards.
• Exceptional communication, influencing, and leadership capabilities.
• Strong problem-solving skills with a proactive and solutions-driven mindset.
• Ability to work onsite and engage closely with lab, manufacturing, and technical teams.
• High integrity and commitment to patient safety and product quality.

Additional Information

• Work Model: Fully onsite in Boston; daily leadership presence required.
• Travel: Occasional domestic or international travel to partners, CMOs, or regulatory meetings.
• Compensation: Competitive executive-level compensation including base salary, bonus, equity, and benefits.