[Hiring] Associate Director, Clinical Quality Assurance @Vera Therapeutics

Role Description

The Associate Director, Clinical Quality Assurance, will report to the Executive Quality Assurance. This role serves as a key quality partner to clinical study teams and provides quality oversight of clinical development activities. The position contributes to strengthening a maturing Quality Management System (QMS) by:

• Identifying quality risks
• Supporting risk-based decision making
• Ensuring quality practices are effectively implemented across clinical programs

The Clinical Quality Assurance organization partners with Clinical Development and cross-functional stakeholders to promote and maintain high-quality clinical research practices across the drug development lifecycle. This role provides proactive Clinical Quality Assurance oversight for clinical studies and development functions, including:

• Partnering closely with Clinical Operations, Pharmacovigilance, Data Management, Regulatory Affairs, and other development functions
• Identifying quality issues and risks
• Reviewing quality events, investigations, and CAPAs
• Analyzing quality signals across studies and vendors
• Ensuring quality management practices are appropriately implemented throughout the clinical trial lifecycle

The role operates with a high degree of independence in evaluating quality risks and compliance considerations while collaborating closely with cross-functional teams to support effective implementation of quality practices across clinical development programs.

The position also contributes to strengthening the organization’s maturing Quality Management System (QMS) by:

• Supporting procedural governance
• Audit program oversight
• Quality process improvement initiatives

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.
• 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.
• Review and provide input on new or revised SOPs and controlled documents to ensure alignment with regulatory requirements.
• 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.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, or related scientific discipline required; advanced degree preferred.
• 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)
• 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.

Requirements

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively in a team environment.
• Detail-oriented with a focus on quality and compliance.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health benefits.
• Retirement savings plan with company match.
• Generous paid time off and holidays.