Senior Manager, Quality Assurance
Olema Oncology(1 month ago)
About this role
The Sr. Manager, GCP Clinical Quality partners with Clinical Development/Operations and Pharmacovigilance to ensure GCP/GVP compliance across clinical studies and to support inspection readiness and audits. The role reports to the Senior Director, GCP Quality and contributes to quality systems, regulatory inspection support, and continuous improvement of risk-based GCP compliance. This hybrid position is based in San Francisco, CA or Cambridge, MA with up to 20% travel.
Required Skills
- GCP Compliance
- GVP Compliance
- Auditing
- Inspection Readiness
- Audit Preparation
- Audit Reporting
- CAPA Management
- QMS
- SOP Writing
- Regulatory Inspections
+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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