Senior Manager, GCP Quality Assurance
Olema Oncology(1 month ago)
About this role
The Senior Manager, GCP Clinical Quality is responsible for ensuring clinical program compliance with GCP and GVP standards and supporting the company’s inspection readiness and audit activities. This cross-functional role partners with Clinical Development, Pharmacovigilance, and Safety and contributes to continuous improvement of quality systems. The position is hybrid based in San Francisco, CA or Cambridge, MA and requires up to 20% travel.
Required Skills
- GCP
- GVP
- Auditing
- Regulatory Inspections
- QMS
- eTMF
- EDC
- Pharmacovigilance
- SOP Writing
- CAPA Management
+5 more
Qualifications
- Bachelor's Degree
- MS
- PharmD
- PhD
About Olema Oncology
olema.comOlema Oncology is a cancer medicines company focused on innovating therapies for breast cancer and other endocrine-driven tumors. The company is rapidly advancing a pipeline of drug candidates designed to target the biology of endocrine-driven disease. Olema’s work centers on translating cutting‑edge science into treatments that meaningfully impact patients, progressing programs toward clinical evaluation.
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