A well-established Biotechnology firm is currently seeking a driven and organized Sr. Clinical Quality Consultant with a strong background in Quality management systems and pharmaceutical development. They are looking to bring someone on the team as they are expanding their portfolio. You would primarily be developing and maintaining quality programs, processes, procedures, and systems in accordance to established standards and agency guidelines.
- Lead the processes and system owners in reviewing quality oversight data.
- Manage clinical quality aspect of clinical trials to ensure vendor oversight.
- Work with cross-functional teams to develop and implement quality plans to reduce risk to clinical trial quality.
- Identify and address places of error and improvement from internal audits and regulatory inspections.
- Lead process improvement and system initiatives related to quality processes
- 5+ years of pharmaceutical or biotechnology industry experience.
- Industry experience in GCP auditing and inspections
- Experience in Clinical development or supporting clinical trials or operations management
- Experience in risk assessment, prospective indicators, and root cause analysis of quality issues.
- Experience in the Oncology Therapeutic trial design space and general oncology therapeutic area knowledge.
If you are interested in the Sr. Clinical Quality Consulting role, then please don't wait to apply!