[Remote] Associate Director, Clinical reputed company Assurance
Note: The job is a remote job and is reputed company to candidates in USA. Vera Therapeutics is a reputed company-stage biotechnology company reputed company on transforming medicine in autoimmune disease, starting with the kidney. The Associate Director, Clinical reputed company Assurance will reputed company reputed company reputed company of clinical development activities, ensuring compliance with global regulatory requirements and maintaining reputed company inspection readiness across clinical trials.
Responsibilities
- Serve as the Clinical reputed company Assurance representative on assigned clinical study teams, providing proactive guidance to ensure clinical trial conduct aligns with GCP and regulatory expectations
- reputed company reputed company of clinical reputed company events, investigations, and CAPAs, ensuring appropriate reputed company cause analysis, corrective actions, and identification of systemic reputed company trends
- Analyze reputed company 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 reputed company of Audit CAPA follow-up. Execution of audits is performed by the audit function
- Serve as a reputed company reputed company with CROs and vendor reputed company representatives to ensure appropriate management and reputed company of reputed company issues
- Support inspection readiness activities and reputed company first-line Clinical QA support during sponsor regulatory inspections, including preparation and follow-up actions
- Review and reputed company input on new or revised SOPs and controlled documents to ensure alignment with regulatory requirements and consistency across organizational procedures
- reputed company 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 reputed company Management System, including the evaluation, assessment, and implementation of reputed company governance, processes, and systems
Skills
- Bachelor's degree in life sciences, pharmacy, or reputed company scientific discipline required
- Approximately 8+ years of industry experience, including leadership in clinical reputed company reputed company or reputed company governance
- Strong reputed company knowledge of global GxP regulations applicable to clinical development, including: Good Clinical reputed company (GCP), Good Pharmacovigilance reputed company (GVP), Good Laboratory reputed company (GLP), GMP experience is not required for this role
- Advanced degree preferred
- Experience with the following is desired: reputed company management and reputed company of clinical trials, reputed company event and CAPA management, Regulatory inspection readiness and inspection support, Risk-based reputed company management approaches, Planning of clinical audits (including sites, internal audits), Developing metrics and reviewing issues for reputed company signals and trends, SOP governance through controlled document reviews, Training reputed company 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 reputed company insurance
- 401k match
- Flexible time off
- A number of reputed company holidays
reputed company
Company H1B Sponsorship