Associate Director, Clinical Quality
Obsidian TherapeuticsCambridge, Massachusetts, United States
Posted December 9, 2025
171500 - 210000 USD year
Full Time
About the Company
Obsidian Therapeutics is a biotech company pioneering engineered cell and gene therapies.
Job Description
Obsidian Therapeutics is seeking an Associate Director, Clinical Quality to support the advancement of clinical trials in metastatic melanoma and non-small cell lung cancer. The successful candidate will be responsible for developing and executing a GCP Clinical Quality Assurance program to ensure compliance with applicable regulations.
Requirements
- Define and implement a risk-based GCP quality management system
- Develop an audit program and conduct internal and external GCP audits
- Manage the audit lifecycle activities
- Present audit findings and escalate serious non-compliance issues
- Work directly with auditees to ensure completion of corrective and preventative actions
- Identify non-compliance trends, gaps, and implement mitigation strategies
- Review study documents to assess GCP compliance
- Support investigation and closure of GCP related deviations/quality events/CAPAs
- Collaborate with Clinical Operations, Technical Operations teams and CRO counterparts
- Support Quality Management in inspection readiness activities
Benefits
- Comprehensive medical, dental, and vision coverage
- Company contributions to health savings and retirement accounts
- Ample paid time off
- Access to wellness programs
- Rich career growth opportunities