Note: The job is a remote job and is open to candidates in USA. Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. The Associate Director, Clinical Quality Assurance, will provide quality oversight of clinical development activities and ensure compliance with global regulatory requirements while supporting the organization's Quality Management System.
Responsibilities
- Serve as the Clinical Quality Assurance representative on assigned clinical study teams, providing proactive guidance to ensure clinical trial conduct aligns with GCP and regulatory expectations
- Provide oversight of clinical quality events, investigations, and CAPAs, ensuring appropriate root cause analysis, corrective actions, and identification of systemic quality trends
- Analyze quality signals across studies, vendors, and operational processes to identify emerging risks and recommend mitigation strategies
- Contribute to governance of the clinical audit program, including risk-based selection of audits and oversight of Audit CAPA follow-up. Execution of audits is performed by the audit function
- Serve as a quality interface with CROs and vendor quality representatives to ensure appropriate management and resolution of quality issues
- Support inspection readiness activities and provide first-line Clinical QA support during sponsor regulatory inspections, including preparation and follow-up actions
- Review and provide input on new or revised SOPs and controlled documents to ensure alignment with regulatory requirements and consistency across organizational procedures
- Provide input on training assignments and training matrices to ensure procedures are appropriately implemented across functional roles
- Participate in process improvement initiatives that support the development and strengthening of the Quality Management System, including the evaluation, assessment, and implementation of quality governance, processes, and systems
Skills
- Bachelor's degree in life sciences, pharmacy, or related scientific discipline required
- Approximately 8+ years of industry experience, including leadership in clinical quality oversight or quality governance
- Strong applied knowledge of global GxP regulations applicable to clinical development, including: Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practice (GLP), GMP experience is not required for this role
- Advanced degree preferred
- Experience with the following is desired: 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 are considered a plus
Benefits
- Annual performance incentive bonus
- New hire equity
- Ongoing performance-based equity
- Medical, dental, and vision insurance
- 401k match
- Flexible time off
- A number of paid holidays
Company Overview
Company H1B Sponsorship