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Senior Manager, Quality Document Control and Compliance

Olema OncologyBoston, Massachusetts
On-site Full-time $150K/yr - $160K/yr

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Experience Level

Senior Level Manager

Qualifications

To excel in this role, you should possess a solid background in quality management systems, particularly with experience in GxP compliance and document control processes. Strong organizational skills and attention to detail are essential, along with the ability to work collaboratively across departments. Familiarity with Veeva Vault QDocs is highly desirable.

About the job

At Olema Oncology, we are committed to innovating and advancing the field of breast cancer treatment and beyond. Our flagship program, palazestrant (OP-1250), is a pioneering complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer, showcasing significant potential as both a standalone therapy and in combination with other treatments for ER+/HER2- metastatic breast cancer. Additionally, our subsequent product candidate, OP-3136, is a KAT6 inhibitor that stands out as best-in-class.

We believe that our scientific achievements are propelled by a collaborative environment where we support, inspire, and challenge each other. At Olema, prioritizing the well-being of our team translates into exceptional results. If you are ready to be part of a transformative journey that deeply impacts the lives of our patients and enhances your career, we invite you to join us.

For more insights, please check our latest corporate presentations here.

About the Role: Senior Manager, Quality Document Control and Compliance

The Senior Manager of Quality Document Control and Compliance will be a key player in our operations, reporting directly to the Director of Quality Systems. This role will oversee the daily operations of Veeva Vault QDocs, leading document management processes and ensuring compliance standards are met. Responsibilities include but are not limited to the creation and processing of document change control documentation in Veeva QDocs, management of standard operating procedures (SOPs), and GXP documentation, as well as overseeing GXP record processing and archival. You will also be responsible for maintaining document control compliance KPIs and generating metrics for management review.

This position is based in our Boston, Massachusetts office and may require approximately 15% travel.

Your primary responsibilities will encompass:

  • Acting as the Veeva Vault QDocs Administrator and document control manager.
  • Processing document change control (DCC) for GxP controlled documents in Veeva.
  • Formatting finalized documents to adhere to effective templates.
  • Proofreading and finalizing documents for processing in Veeva QDocs.
  • Collaborating closely with various functional areas to develop, update, manage, and maintain GxP controlled documents.

About Olema Oncology

Olema Oncology is at the forefront of medical innovation, striving to create groundbreaking therapies for breast cancer and beyond. Our team is passionate about making a difference and is dedicated to fostering a supportive environment that encourages growth and collaboration.

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