The QA department of a thriving oncology company is looking to add a Clinical Quality Assurance manager to their team. This public company is well established with an impressive pipeline and multiple products in phase 3 trails.
- Maintain Clinical QA compliance program
- Assist with biostatistician and clinical audits
- Perform clinical and vendor audits
- Draft quality agreements with vendors
- Serve as subject matter expert for GCP issues
- Travel 20% of time
- 3+ years' experience in CQA in a pharmaceutical or biotech industry
- 2+ years' experience with project management in a clinical setting
- Understanding of FDA and ICH guidelines
Sthree US is acting as an Employment Agency in relation to this vacancy.