Associate Director, GMP Quality
About this role
About the Role Olema Oncology is seeking an Associate Director, GMP Quality to lead and supervise GMP quality programs essential for the development and potential commercialization of palazestrant. The role will ensure compliance with cGMP, drive quality systems, and partner with cross-functional teams to support late-stage clinical programs and the transition to commercial readiness in breast cancer therapy. What You'll Do
- Lead the GMP Quality program across manufacturing and testing activities, ensuring compliance with FDA regulations and ICH guidelines.
- Develop, implement, and maintain quality systems, SOPs, deviation investigations, CAPAs, change control, and batch record review.
- Lead internal and external audits (supplier/audit readiness) and manage CAPA closure.
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