Sr. Manager, QA

SUMMARY

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.

DUTIES AND 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
• Partner cross-functionally with Clinical Operations, Manufacturing, Regulatory Affairs, and R&D to align on quality requirements and operational execution
• Influence cross-functional decision-making related to quality, compliance, and risk management
• Communicate quality system performance, risks, and priorities to senior management and key stakeholders
• Delegate work, manage priorities, and ensure alignment of team deliverables with departmental and organizational goals
• Foster a culture of accountability, quality, and continuous improvement across the team and broader organization
• Lead or sponsor cross-functional initiatives to improve quality system effectiveness and operational performance
• Mentor junior staff and contribute to knowledge sharing across the organization

EDUCATION AND EXPERIENCE

• Bachelor’s degree in life sciences, health sciences, or related field (advanced degree preferred)
• Minimum 8 years of experience in the cGMP pharmaceutical or biotechnology industry; Latestage clinical to commercial manufacturing environments and/or Stem cell manufacturing experience is preferred.
• Experience with electronic QMS and/or electronic batch record (EBR) systems is a plus.
• Minimum 5 years of experience in conducting internal and external audits; Certified Quality Auditor (CQA) or equivalent preferred.
• Minimum 5 years of direct people management or supervisory experience