Director, GMP and Quality Systems Compliance
Olema Oncology(1 month ago)
About this role
The Director, GMP and Quality Systems Compliance is a senior Quality Assurance role responsible for ensuring company-wide adherence to GMP and quality standards as Olema advances toward commercial operations. The position supports development of regulatory intelligence and inspection readiness capabilities across the supplier and contract service provider network, and contributes to compliance strategy for the company’s oncology programs.
Required Skills
- Supplier Quality
- Inspection Readiness
- Regulatory Intelligence
- Compliance Monitoring
- Audit Management
- Quality Systems
- Inspection Software
- Generative AI
- Risk Assessment
- Supplier Audits
+5 more
Qualifications
- Bachelor's Degree in Biology
- Pharmaceutical Auditor Certification (Preferred)
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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