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Vice President of Quality Assurance

Olema OncologyBoston, Massachusetts
Hybrid Full-time $315K/yr - $340K/yr

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Experience Level

Senior Level Manager

Qualifications

Qualifications for this role include a proven track record in quality assurance leadership within the pharmaceutical or biotech industry, specifically in oncology. A strong understanding of regulatory requirements and compliance, along with experience in developing quality systems and processes, is essential. Exceptional communication and interpersonal skills are necessary to effectively collaborate across various teams and engage with regulatory agencies.

About the job

Olema Oncology is dedicated to advancing new treatments for breast cancer, with a focus on therapies such as palazestrant (OP-1250), a complete estrogen receptor antagonist (CERAN) in development for metastatic breast cancer. The company’s pipeline also includes OP-3136, a KAT6 inhibitor. Olema’s team works in an environment that values support, motivation, and challenge, all aimed at driving scientific progress and meaningful outcomes for patients.

Role overview

The Vice President of Quality Assurance leads Olema’s global quality strategy and governance across the entire product lifecycle. This includes oversight of clinical development, manufacturing, pharmacovigilance, and commercial operations. As the senior Quality representative at the executive level, this leader ensures a risk-based approach tailored to the needs of oncology drug development, with a strong focus on patient safety, data integrity, and timely execution.

The Vice President operates with significant autonomy, collaborating closely with leaders across the company and guiding the established Quality leadership team in GCP, GMP, and GPV. Setting priorities, driving execution, and maintaining inspection readiness are central as Olema advances toward late-stage development.

This position is based in Boston, MA or San Francisco, CA, and requires some travel.

Key responsibilities

  • Develop and implement a pragmatic, phase-appropriate, and cohesive Quality strategy that aligns with Olema’s pipeline and corporate goals.
  • Act as the senior authority for Quality within the organization, establishing standards and practices to support ongoing and future initiatives.

For more information on Olema Oncology’s work and updates, see their corporate presentations.

About Olema Oncology

Olema Oncology is a pioneering biotechnology firm focused on developing groundbreaking therapies for breast cancer and other oncological conditions. Our commitment to innovation and patient-centered care drives our mission to redefine treatment paradigms and improve outcomes for patients worldwide.

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