Associate Director, Clinical Quality Assurance
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Job Description
Associate Director overseeing clinical quality assurance at Vera Therapeutics focusing on immunological disease treatments. Collaborating with clinical study teams to maintain quality standards and compliance.
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.
Requirements:
- 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:
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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