About the job
At Olema Oncology, we are committed to pioneering innovative treatments for breast cancer and beyond. Our flagship product, palazestrant (OP-1250), stands out as a complete estrogen receptor antagonist (CERAN) currently in clinical trials for metastatic breast cancer, boasting remarkable potential both as a standalone treatment and in combination therapies for ER+/HER2- metastatic breast cancer. Our subsequent candidate, OP-3136, is a leading KAT6 inhibitor with exceptional therapeutic promise.
Our scientific advancements are propelled by a culture that empowers, inspires, and encourages one another. At Olema, we believe that prioritizing our people leads to unparalleled outcomes. If you are eager to be part of something transformative, join us in making a significant difference for our patients, your career, and the future of medicine.
You can view our latest corporate deck and presentations here.
About the Role: Senior Manager, Quality Document Control and Compliance
The Senior Manager, Quality Document Control and Compliance will collaborate closely with the Director of Quality Systems, spearheading daily operations of Veeva Vault QDocs along with the entire document management process and compliance. Responsibilities include the creation and management of document change control (DCC) documentation within Veeva QDocs, overseeing standard operating procedures (SOPs) and other GXP documentation, processing and archiving GXP records, and maintaining document control compliance KPIs while compiling and reporting metrics for management review.
This position is located at our San Francisco, CA or Cambridge, MA office, with approximately 15% travel required.
Your primary responsibilities will include:
- Acting as the Veeva Vault QDocs Administrator and document control manager.
- Processing document change control (DCC) for GxP controlled documents in Veeva.
- Ensuring finalized documents adhere to compliance with effective templates.
- Proofreading and finalizing documents for processing in Veeva QDocs.
- Developing, updating, managing, and maintaining GxP controlled documents in close collaboration with functional area representatives.
