Director, GMP and Quality Systems Compliance
Olema Oncology(1 month ago)
About this role
The Director, GMP and Quality Systems Compliance at Olema leads and oversees company-wide GMP and quality systems compliance as the organization advances toward commercial operations. This senior role establishes and maintains regulatory readiness and a Regulatory Intelligence function to inform strategy and protect product quality. The position is based in Cambridge, MA or San Francisco, CA and involves regular cross-functional collaboration and up to 25% travel.
Required Skills
- Supplier Quality
- Inspection Readiness
- Regulatory Intelligence
- Compliance Monitoring
- Quality Improvement
- Quality Reviews
- Audit Management
- AI Tools
- Inspection Software
- Supplier Audits
+6 more
Qualifications
- Bachelor's Degree in Biology or Related Scientific Field
- 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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