Olema Oncology

Associate Director, GMP Quality

Boston, Massachusetts · Director

Sponsorship not specified$10k-$15kDetected 7 days ago

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About the role

Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond.
OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients.
Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape - particularly in combination with palazestrant.

Review and approval of CMO Deviations, CAPA, and Change Controls and opening of internal shadow records when required
Experience with small molecule synthesis and analytical test record review
Prior experience with NDA/BLA submission and commercial launch for pharmaceutical products
Experience with Quality Management Systems such as Veeva or TrackWise

Bachelor's degree is required
advanced degree (MS, PharmD, PhD) preferred
Extensive understanding and knowledge of industry standards, concepts and current cGMP (21 CFR Parts 210 and 211), EudraLex Volume 4, ICH Q7 and other agency standards and guidance as they relate to GMP Quality Assurance

Contribute and participate in Annual Product Quality Reviews of commercial products

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To protect yourself, please note that Olema's official email addresses end in @olema.com.
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This listing is sourced directly from Olema Oncology's careers page and normalized into a canonical job model.