Director, Clinical Quality Assurance
Angitia Incorporated LimitedHawaii, United States
Posted October 29, 2025
180000 - 230000 USD year
Full Time
About the Company
Angitia Incorporated Limited is a clinical-stage biotechnology company dedicated to discovering and developing innovative therapeutics for serious musculoskeletal diseases. Focusing on areas such as bone, cartilage, and muscle, Angitia leverages its team's expertise in new drug development to address unmet medical needs, bringing cutting-edge treatments to patients.
Job Description
The Director of Clinical Quality Assurance will be responsible for ensuring the quality and compliance of Angitia sponsored clinical studies related to Standard Operating Procedures, regulatory requirements (FDA, ICH), and GLP studies. This role involves team leadership, process development, audit readiness, and ensuring GxP compliance. It reports to the VP, Head of Global Clinical Operations.
Requirements
- BS BA (or equivalent) in a relevant scientific discipline
- 10+ years of Biotechnology industry experience
- 10+ years of experience in Quality Assurance
- Strong knowledge of GCP, GLP, and ICH clinical study requirements
- Experience with both domestic and international clinical studies
- Experience building a quality program and quality system
- Experience leading audits of GXP vendors as well as clinical sites
- Demonstrated problem-solving and critical thinking skills
- Excellent interpersonal, written, and verbal communication skills
- Excellent computer skills (MS Word, PowerPoint, Excel, etc.)
- Up to 25% travel
Benefits
- Medical, dental, and vision coverage
- 401(K) Retirement Plan
- Company paid Long Term Disability Coverage
- Company-paid life Insurance & AD&D Coverage
- Voluntary Life Insurance & AD&D Coverage
- Employee Assistance Program
- Company-paid Holidays
- Vacation
- Paid Sick Leave
- Work-From-Home Equipment Reimbursement
