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Associate Director GMP Quality at Olema Oncology - ApplyBlast

Associate Director GMP Quality

Olema Oncology

3 months ago

3.8 on Glassdoor

San Francisco, California, United States

Onsite

Full Time

Director

0 applicants

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About this role

The Associate Director, GMP Quality will oversee GMP activities for Olema Oncology's clinical and commercial products, focusing on small molecule drug substance manufacturing, analytical review, and supplier compliance. The role involves cross‑functional collaboration with CMC, Regulatory, and Supply Chain teams, as well as representing the company during inspections and submissions.

Responsibilities

Oversee batch disposition and release for clinical and commercial materials
Review and approve CMO deviations, CAPA, and change controls
Perform technical review of quality control records and certificates of analysis
Represent company as Person in Plant during critical processing
Support NDA/BLA submissions and pre‑approval inspection readiness

Skills

Qualifications

Bachelor's degreeMSPharmDPhD

About Olema Oncology

olema.com

Headquarters

San Francisco, California, United States

Company Size

51-200 employees

Founded

2007

View Profile

Olema Oncology is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel targeted therapies for metastatic breast cancer and beyond. The company leverages its deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance to advance its pipeline, including Phase 3 breast cancer trials and a KAT6 inhibitor program being evaluated in solid tumors and prostate cancer. Founded in 2006 and headquartered in San Francisco, California, Olema trades on Nasdaq under the ticker OLMA.