[Hiring] Manager, Quality Assurance @Care Access

Role Description

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 support
• Vendor review and qualification
• SOP development and review
• Investigation of quality events
• Root cause analysis and CAPA management
• Training and continuous improvement initiatives
• 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 accountability, supported by:

• Embedded quality support
• Independent quality auditing and oversight
• Comprehensive SOPs and training
• Robust quality control
• Proactive CAPA framework

The Manager, Quality Assurance partners across the organization to strengthen inspection readiness and contribute to a global culture where quality is a personal mandate and continuous improvement is expected.

Qualifications

• Ability to work independently and manage multiple assignments
• Strong communication skills to develop collaborative relationships
• Strong interest in clinical research and health services
• Openness to innovative and compliant approaches
• Technical proficiency in eQMS and various software

Requirements

• A bachelor’s degree is preferred with a minimum of 1-3 years’ experience in clinical research-related quality assurance or compliance roles
• Clinical trial experience for a site, site network or CRO is required
• Knowledge of GCP auditing techniques is preferred
• Certification as a clinical auditor is a plus but not required

Benefits

• Paid Time Off (PTO) and Company Paid Holidays
• 100% Employer paid medical, dental, and vision insurance plan options
• Health Savings Account and Flexible Spending Accounts
• Bi-weekly HSA employer contribution
• Company paid Short-Term Disability and Long-Term Disability
• 401(k) Retirement Plan, with Company Match