Associate Director, Clinical Quality Assurance

Vera Therapeutics, Inc.; United States; Sur place; USD 140 000 - 210 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision insurance

401k match

Flexible time off

Résumé du poste

Vera Therapeutics, Inc. is seeking an Associate Director, Clinical Quality Assurance to enhance the quality management system within clinical development units. In this key role, you will oversee clinical quality events and foster compliance with regulations while ensuring best practices across programs.

The ideal candidate will have a Bachelor's degree and over 8 years in clinical quality assurance, alongside expertise in risk management and inspection readiness. Competitive compensation and benefits are offered, including performance bonuses and stock equity.

Qualifications

• Approximately 8+ years of industry experience including leadership in clinical quality oversight.
• Strong applied knowledge of global GxP regulations applicable to clinical development.
• Relevant certifications such as RQAP, CQA, CCRC, or RAC are considered a plus.

Responsabilités

• 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 to identify emerging risks.
• Contribute to governance of the clinical audit program.
• Support inspection readiness activities during regulatory inspections.

Connaissances

Leadership in clinical quality oversight

Quality event and CAPA management

Risk-based quality management

Regulatory inspection readiness

Developing metrics and reviewing quality signals

Formation

Bachelor’s degree in life sciences, pharmacy, or related discipline

Advanced degree preferred

Description du poste

Company Overview

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell–mediated diseases. Vera Therapeutics is also evaluating the development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109, and MAU868. For more information, please visit www.veratx.com.

Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

Position Summary

The Associate Director, Clinical Quality Assurance will report to the Executive Director, Quality Assurance. The Associate Director, Clinical Quality Assurance serves as a key quality partner to clinical study teams and provides quality oversight of clinical development activities. This role contributes to strengthening a maturing Quality Management System (QMS) by identifying quality risks, supporting risk-based decision making, and 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. The function provides quality oversight to ensure clinical trials are conducted in compliance with global regulatory requirements and that the organization maintains continuous inspection readiness. This role provides proactive Clinical Quality Assurance oversight for clinical studies and development functions. The individual partners closely with Clinical Operations, Pharmacovigilance, Data Management, Regulatory Affairs, and other development functions and serves as a key member of study teams, helping identify quality issues and risks, and reviews quality events, investigations, and CAPAs; analyzing quality signals across studies and vendors that support risk‑based decision making, and 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 contributes to strengthening the organization’s maturing Quality Management System (QMS) by supporting procedural governance, audit program oversight, and 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. 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.

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)
  • GMP experience is not required for this role
• 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

Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience. For this role, the anticipated base pay range is $140,000 - $210,000 USD. At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance‑based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.

Vera Therapeutics Inc. is an equal‑opportunity employer.