Senior Manager, Quality Assurance

About the role

The Senior Manager, Quality Assurance leads the execution, maintenance, and ongoing improvement of GxP quality systems and teams that support Phase 2a through Phase 3 clinical and manufacturing operations. The role ensures compliance with GMP, GCP, and GLP requirements through direct oversight of key QA processes, including document control, training, supplier quality, deviations/CAPA, and batch disposition. This is a hybrid “player-coach” position that combines hands-on individual contributor responsibilities with leadership of junior quality team members, including performance management, strategy, and administrative oversight.

Responsibilities

• Establish and execute operational objectives and work plans for GxP quality systems aligned with organizational and program priorities
• Contribute to the development, implementation, and continuous improvement of QA policies, procedures, and standards affecting clinical and manufacturing operations
• Drive optimization and scalability of quality systems to support late-stage clinical development and commercial readiness
• Manage and continuously improve multiple QA functional areas, including document control, training systems, supplier quality, quality events (deviations, CAPA, change control, nonconformance), and batch disposition
• Ensure compliant and timely execution of core QMS processes, including investigation closure, documentation accuracy, and adherence to regulatory expectations
• Establish and monitor quality metrics, trends, and reporting to assess system effectiveness and identify risks
• Lead and coordinate inspection readiness activities, ensuring ongoing audit preparedness across quality systems and operations
• Oversee internal, external, and regulatory audit activities, including preparation, execution, and timely resolution of findings
• Ensure appropriate identification, escalation, and mitigation of quality and compliance risks with potential operational or regulatory impact