Manager, Quality Assurance

Care Access

11d•Hybrid

About The Position

The Manager, Quality Assurance plays a critical role in advancing Care Access's 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.

Requirements

Ability to work independently, remain objective, and manage multiple assignments and competing priorities.
Ability to remain flexible and work in evolving regulatory environments and understand different quality frameworks for different programs or service lines across our company portfolios.
Strong communication skills to develop collaborative working relationships and support sponsor, client or regulatory communications to enhance the impact of quality support.
Strong interest in clinical research and health services, including knowledge of clinical trial site operations, protocol deviation management, regulatory frameworks and sponsor perspectives.
Display an openness to innovative and compliant approaches to conducting research and health services activities.
Ability to prioritize business objectives while maintaining high attention to detail.
Technical proficiency required to work daily in eQMS and utilize various software and platforms across the business.
Ability to communicate written and verbally and communicate findings effectively to senior leaders.
A bachelor’s degree is preferred with a minimum of 1-3 years’ experience in clinical research-related quality assurance or compliance roles or clinical auditing. Years of experience in clinical research-related roles may be substituted for degree requirements on a year-per-year basis. Site experience is valued.
Clinical trial experience for a site, site network or CRO is required.
Knowledge of GCP auditing techniques is preferred but may be transferable through other work experiences across GxP auditing, quality control, or five or more as a clinical research coordinator with quality related experiences.

Nice To Haves

Certification as a clinical auditor is a plus but not required.

Responsibilities

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.
Provide quality and compliance support on sponsor audits, client audits, and regulatory inspections.
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.
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, and source documents for accuracy.
Promote a culture of inspections readiness and continuous improvement. Be flexible to work with risk-based audit agendas and shifting priorities.
Be knowledgeable of evolving GxP guidelines. Ability to critically think, eagerness to learn, and commitment to ensuring compliance. Knowledge of and able to interpret regulatory guidances such as 21 CFR Part 11/ Part 312, ICH GCP E6 (R3).
Create and deliver training on Quality and Continuous Improvement activities
Support completion of RFP/RFI (Request for proposals/information)
Learn and engage with digital technologies, including artificial intelligence
Support drafting for or conduct quality reviews of SOPs and provide support of SOP management
Provide AI project quality support, QC and consultation
Support other activities related to the management of QMS and accuracy of data
Support GxP and non GxP quality issues and/or projects needing quality consultation and support