Manager, Quality Assurance

How This Role Makes a Difference

The Manager, Quality Assurance plays a critical role in advancing our fundamental commitment of accelerating access to new medicines and health screenings while meeting our own high standards. Supporting Care Access and Reify Health, this role drives quality management system activities including auditing, inspection readiness and audit and inspection support, vendor review and qualification, SOP development and review, investigation of quality events, root cause analysis, and CAPA management, and training, continuous improvement or quality-by-design initiatives, and support for RFPs/RFIs.

This role helps ensure that patient safety, data integrity, regulatory compliance, and continuous improvement are embedded in everything we do. Quality at Care Access is built on strong systems and even stronger accountability, supported by both embedded quality support and independent quality auditing and oversight, comprehensive SOPs and training, robust quality control, and a proactive CAPA framework that identifies, corrects, and prevents issues at their source.

The Manager, Quality Assurance partners across the organization to strengthen inspection readiness and contributing to a global culture where quality is a personal mandate and continuous improvement is expected. By enabling consistent compliance with global regulatory standards, ICH guidelines, and internal procedures, this role helps ensure that every study is conducted with rigor, transparency, and a shared commitment to delivering high-quality clinical research that improves lives.

How You'll Make An Impact

Duties include but are not limited to:

• Internal Auditing: independently lead and conduct internal audits and related GxP activities including Investigator site audits, process audits, vendor qualifications, vendor audits, and other specialized audits or quality investigations as defined by leadership.
• External audits: provide quality and compliance support on sponsor audits, client audits, and regulatory inspections.
• Quality Issue/CAPA management: support RCA/CAPA development, tracking, and completion. Works with department to implement and verify CAPAs. Evaluate audit findings, review Quality Issue classification, and review documentation related to QI management. Perform effectiveness checks.
• Documentation and reporting: Produce clear and evidence-based quality systems documentation. Display report writing capabilities and an ability to work within timelines. Be organized and capable of demonstration of ALCOAC. Review informed consent forms, investigator site files, an