Associate Director, Clinical Quality Assurance

The role

The Associate Director, Clinical Quality Assurance provides quality oversight of clinical development activities. This person serves as a quality partner to clinical study teams and helps strengthen the Quality Management System.

What you will do

• Serve as the Clinical Quality Assurance representative on assigned clinical study teams.
• Provide oversight of clinical quality events, investigations, and CAPAs.
• Analyze quality signals across studies, vendors, and operational processes.
• Contribute to governance of the clinical audit program.
• Serve as a quality interface with CROs and vendor quality representatives.
• Support inspection readiness activities and provide first-line Clinical QA support during sponsor regulatory inspections.
• Review and provide input on new or revised SOPs and controlled documents.
• Provide input on training assignments and training matrices.
• Participate in process improvement initiatives for the Quality Management System.

Required qualifications

• Bachelor’s degree in life sciences, pharmacy, or related scientific discipline
• Approximately 8+ years of industry experience, including leadership in clinical quality oversight or quality governance
• Strong applied knowledge of global GxP regulations including Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Laboratory Practice (GLP)

Nice to have

• Advanced degree
• Quality management and oversight of clinical trials
• Quality event and CAPA management
• Regulatory inspection readiness and inspection support
• Risk-based quality management approaches
• Planning of clinical audits (including sites, internal audits)
• Developing metrics and reviewing issues for quality signals and trends
• SOP governance through controlled document reviews
• Training matrix or training governance activities
• Relevant certifications such as RQAP, CQA, CCRC, or RAC

Benefits

• medical, dental, and vision insurance
• 401k match
• flexible time off
• paid holidays

About the company

Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. The company was founded in 2016 and is based in Brisbane, California.