Full-Time

Vice President Quality Assurance

Quality Assurance

Olema Oncology

Olema Oncology

51-200 employees

Clinical-stage biopharma targeting ER-positive breast cancer

Compensation Overview

$315k - $340k/yr

+ Equity + Bonus

Boston, MA, USA + 1 more

More locations: San Francisco, CA, USA

In Person

Two on-site locations; some travel required.

Master's, PharmD, PhD

Category
QA & Testing
Required Skills
Risk Management

Get referred to Olema Oncology

See people who can refer or advise you

Requirements
  • Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS)
  • Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirements
  • Expertise across GCP, GMP, and GPV Quality domains
  • Strong understanding of Quality systems, governance, and inspection readiness practices
  • Working knowledge of oncology drug development
  • Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility
  • Significant people management and leadership experience, including leading senior team members
  • Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors
  • Demonstrated experience across GCP, GMP, and GPV environments
  • Proven track record supporting programs from clinical development through late-stage or commercial readiness
  • Experience leading regulatory inspections and interacting with global health authorities
  • Experience implementing and maintaining Quality systems and compliance frameworks
Responsibilities
  • Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema’s pipeline and corporate objectives
  • Serve as the senior Quality leader, establishing clear governance, decision-making frameworks, and escalation pathways
  • Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability
  • Foster a culture of quality, integrity, and patient focus across the organization
  • Act as escalation point for significant quality, compliance, and patient safety risks
  • Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains
  • Set expectations and direction for a scalable, integrated, and sustainable Quality Management framework spanning clinical through commercial stages
  • Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across the QA function
  • Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization
  • Establish clear quality metrics and reporting to enable risk visibility and informed decision-making
  • Ensure Quality approaches appropriately support the execution of oncology clinical trials
  • Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity
  • Partner with Clinical and Regulatory to support inspection-ready programs and submissions
  • Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization
  • Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMO oversight and inspection preparedness
  • Provide Quality input into CMC, validation, and supply chain readiness activities
  • Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance
  • Ensure PV systems and vendors are appropriately governed and inspection-ready
  • Partner cross-functionally to support ongoing evaluation of benefit-risk
  • Lead the Company’s approach to regulatory inspections, including preparation and execution
  • Ensure risk-based audit programs across GCP, GMP, and GPV
  • Drive proactive identification and mitigation of quality and compliance risks
  • Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization
  • Provide clear, actionable Quality perspectives to support business decisions
  • Represent Quality in executive discussions and external engagements as needed
Desired Qualifications
  • Strong leadership capability with ability to lead through and develop senior leaders
  • Effective communicator with executive presence and influencing skills
  • Sound judgment and decision-making in complex, risk-based environments
  • Ability to operate effectively in a fast-paced, evolving biotech environment
  • Commitment to quality, compliance, and patient safety

Olema Oncology develops targeted therapies for women’s cancers, with a focus on ER+/HER2- breast cancer. Its lead candidate palazestrant (OP-1250) is a dual CERAN/SERD that blocks estrogen signaling and promotes estrogen receptor degradation. The company is running a Phase 3 trial of palazestrant in combination with CDK4/6 inhibitors and has a collaboration with Novartis to test the therapy with ribociclib and everolimus. A second program, a KAT6 inhibitor, is in preclinical development, targeting epigenetic regulation.

Company Size

51-200

Company Stage

IPO

Headquarters

San Francisco, California

Founded

2007

Get referred to Olema Oncology

See people who can refer or advise you

Simplify Jobs

Simplify's Take

What believers are saying

  • Olema held $461.1 million cash at June 30, 2026, funding multiple readouts.
  • OP-3136 ASCO 2026 data showed tolerability and anti-tumor activity across multiple dose levels.
  • Jason O’Byrne joined as CFO August 13, 2026, stabilizing finance ahead of data releases.

What critics are saying

  • OPERA-01 enrollment finished August 2026, but first top-line data slipped to Q1 2027.
  • Shane Kovacs left January 2026, exposing execution risk during pivotal trials and headquarters relocation.
  • If OPERA-01 fails, Olema becomes a cash-burning single-asset oncology company with existential downside.

What makes Olema Oncology unique

  • Palazestrant targets ER-driven resistance with CERAN plus SERD biology, not standard endocrine recycling.
  • OP-3136 broadens Olema beyond palazestrant, building a second breast-cancer mechanism around KAT6.
  • Novartis supplies ribociclib for OPERA-02, validating Olema’s combination strategy in frontline metastatic disease.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Health Insurance

401(k) Retirement Plan

Remote Work Options

Paid Vacation

Flexible Work Hours

Hybrid Work Options

Stock Options

Wellness Program

Mental Health Support

Phone/Internet Stipend

Home Office Stipend

Professional Development Budget

Conference Attendance Budget

Development Training Programs

Tuition Reimbursement

Professional Certification Support

Adoption Assistance

Parental Leave

Family Planning Benefits

Fertility Treatment Support

Relocation Assistance

Bonus

Equity

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

-1%

2 year growth

0%
BioCentury
Aug 13th, 2026
Vir CFO O'Byrne joining Olema.

Vir CFO O'Byrne joining Olema. Plus: changes at zenas, kamada and more. By BioCentury Staff August 13, 2026 5:12 PM PDT Jason O'Byrne has joined breast cancer company Olema Pharmaceuticals Inc. (NASDAQ:OLMA) as CFO from Vir Biotechnology Inc. (NASDAQ:VIR), where he held the same role. O'Byrne was also CFO of Caribou Biosciences Inc. (NASDAQ:CRBU) and SVP of Finance at Astellas Pharma Inc. (Tokyo:4503)... Just want immediate access to this one article? Purchase it now.

The Registry
Jul 13th, 2026
Olema Oncology leases 38,000 SQFT at Kilroy oyster point, moving headquarters to south san francisco.

Olema Oncology leases 38,000 SQFT at Kilroy oyster point, moving headquarters to south san francisco. Clinical-stage breast cancer company Olema Oncology has committed to 38,176 square feet at Kilroy Re Partner content. 2026 northern california CRE rising stars. Signup for news and special announcements!

The Mirror Democrat and Savanna Times-Journal
May 19th, 2026
Olema Oncology to participate in upcoming investor conferences.

Olema Oncology to participate in upcoming investor conferences. * 7 hrs ago SAN FRANCISCO, May 19, 2026 (GLOBE NEWSWIRE) - Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced that the Company will participate in the following upcoming investor conferences: TD Cowen 7th Annual Oncology Innovation Summit Date and Time: May 26, 2026 at 12:30 p.m. ET Format: Fireside Chat Location: Virtual Jefferies Global Healthcare Conference Date and Time: June 3, 2026 at 8:45 a.m. ET Format: Fireside Chat Location: New York, NY Goldman Sachs 47th Annual Global Healthcare Conference Date and Time: June 9, 2026 at 3:20 p.m. ET Format: Fireside Chat Location: Miami, FL Live webcasts and recordings of these presentations will be available, as permitted by the event host, in the Events and Presentations section of Olema's investor relations website at ir.olema.com. About Olema Oncology 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. Olema is advancing a pipeline of novel therapies by leveraging its deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Its lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD), currently in two Phase 3 clinical trials. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit www.olema.com. Media and Investor Relations Contact Courtney O'Konek Vice President, Corporate Communications Olema Oncology

Woodburn Independent
Apr 29th, 2026
Olema Oncology appoints Prakash Raman, Ph.D., to Board of Directors.

Olema Oncology appoints Prakash Raman, Ph.D., to Board of Directors. GlobeNewswire | Olema Oncology Today at 1:01pm PDT SAN FRANCISCO, April 29, 2026 (GLOBE NEWSWIRE) - Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced the appointment of Prakash Raman, Ph.D., to its Board of Directors. "We are excited to welcome Prakash to Olema's Board of Directors at this important time for the Company as we advance our lead program, palazestrant, through two Phase 3 trials and earlier-stage combination studies, and progress OP-3136, our potential best-in-class KAT6 inhibitor," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "His extensive experience across business development, portfolio strategy, and management will be integral as we prepare for pivotal data from OPERA-01 this fall and continue our transformation into a fully integrated oncology company." Dr. Raman brings over two decades of executive leadership and business development expertise in the biopharmaceutical industry to Olema. He currently serves as Chief Executive Officer of InduPro Therapeutics, a company developing protein therapeutics in oncology and immunology. Prior to this, he was President and Chief Executive Officer of Ribon Therapeutics, a biotechnology company focused on first-in-class small molecule drugs for oncology and immunology. Previously, he served as Senior Partner, Chief Business Development Officer at Flagship Pioneering. This followed nearly 14 years at Novartis where Dr. Raman held roles of increasing responsibility, most recently as Vice President, Global Head of Novartis Institutes for Biomedical Research (NIBR) Business Development and Licensing. While at NIBR, he played a key role in forging strategic collaborations in immuno-oncology and guiding acquisitions, including Advanced Accelerator Applications, Endocyte, IFM Tre, and Selexys, among others. Earlier in his career, Dr. Raman served as a Senior Scientist at Millennium Pharmaceuticals and as a postdoctoral fellow at The Scripps Research Institute. Dr. Raman has served as a member of the Board of Directors of Black Diamond Therapeutics since April 2024. He received his Ph.D. in Organic and Medicinal Chemistry from the University of Wisconsin-Madison and completed his undergraduate studies and a master's degree in Organic Chemistry at the Indian Institute of Technology, Bombay. "I am honored to join Olema's Board of Directors at this exciting stage in the Company's evolution," said Dr. Raman. "I look forward to working with both the Board and members of the Executive Committee to support the advancement of palazestrant and OP-3136, two innovative therapies with the potential to redefine the metastatic breast cancer treatment paradigm and help people living with breast cancer and beyond feel better, longer." "On behalf of the Board of Directors, I am pleased to welcome Prakash to the team," said Ian Clark, Chairman of Olema's Board of Directors. "His deep experience across the biopharmaceutical industry will be invaluable as Olema advances its programs and prepares for its next phase of growth." About Olema Oncology 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. Olema is advancing a pipeline of novel therapies by leveraging its deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Its lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD), currently in two Phase 3 clinical trials. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit www.olema.com. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as "anticipate," "believe," "could," "expect," "goal," "intend," "may," "on track," "potential," "upcoming," "will" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the advancement of Olema's product candidates, including palazestrant and OP-3136; the progress and timing of Olema's clinical trials, including the two Phase 3 trials; the expected timing of pivotal data readouts, including from OPERA-01; the potential of OP-3136 to be a best-in-class KAT6 inhibitor; Olema's plans to evolve into a fully integrated oncology company; the anticipated contributions of new members of the Board of Directors and executive leadership; and the potential of palazestrant and OP-3136, alone or in combination, to provide therapeutic benefit, improve patient outcomes, or redefine the metastatic breast cancer treatment paradigm. Because such statements deal with future events and are based on Olema's current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled "Risk Factors" in Olema's Annual Report on Form 10-K for the year ended December 31, 2025, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Media and Investor Relations Contact Courtney O'Konek Vice President, Corporate Communications Olema Oncology [email protected] This is a paid placement. For further inquiries, please contact GlobeNewswire directly.

Wilsonville Spokesman
Apr 21st, 2026
Olema Oncology to present initial clinical data for OP-3136 at the 2026 ASCO Annual Meeting.

Olema Oncology to present initial clinical data for OP-3136 at the 2026 ASCO Annual Meeting. GlobeNewswire | Olema Oncology Today at 1:01pm PDT SAN FRANCISCO, April 21, 2026 (GLOBE NEWSWIRE) - Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced it will present initial clinical data from the Phase 1 study of OP-3136 in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 29-June 2 in Chicago, Illinois. The Company will also present a trial-in-progress poster for the Phase 3 OPERA-02 trial. Poster Presentation Details Title: A phase 1, first-in-human study of OP-3136, a novel oral selective KAT6A/B inhibitor, as monotherapy in advanced solid tumors and in combination with endocrine therapy in ER+, HER2− advanced breast cancer (ABC): Preliminary results Abstract Number: 3088 Poster Number: 225 Date/Time: May 30, 2026 from 1:30pm-4:30pm CT / 2:30pm-5:30pm ET Title: OPERA-02: A phase 3 study of palazestrant plus ribociclib as first-line treatment of ER+, HER2- advanced breast cancer Abstract Number: TPS1152 Poster Number: 261b Date/Time: June 1, 2026 from 1:30pm-4:30pm CT / 2:30pm-5:30pm ET About Olema Oncology 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. Olema is advancing a pipeline of novel therapies by leveraging its deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Its lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD), currently in two Phase 3 clinical trials. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit www.olema.com. About Palazestrant (OP-1250) Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, central nervous system penetration, and combinability with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated as a single agent in the ongoing pivotal Phase 3 clinical trial, OPERA-01, and in combination with ribociclib in the ongoing pivotal Phase 3 clinical trial, OPERA-02. Palazestrant is also being evaluated in multiple Phase 1/2 studies in combination with ribociclib, palbociclib, alpelisib, everolimus, and atirmociclib. About OP-3136 OP-3136 is a novel, orally available small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), an epigenetic target that is dysregulated in breast and other cancers. In preclinical studies, OP-3136 has demonstrated significant anti-proliferative activity in ER+ breast cancer models and is combinable and synergistic with endocrine therapies including palazestrant and cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The Investigational New Drug (IND) application for OP-3136 was cleared by the U.S. Food and Drug Administration (FDA) in December 2024 and patients are currently enrolling in the Phase 1 clinical study. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as "anticipate," "believe," "could," "expect," "goal," "intend," "may," "on track," "potential," "upcoming," "will" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the potential beneficial characteristics including but not limited to safety, tolerability, activity, efficacy and therapeutic effects of palazestrant or OP-3136 and the combinability of palazestrant or OP-3136 with other drugs. Because such statements deal with future events and are based on Olema's current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled "Risk Factors" in Olema's Annual Report on Form 10-K for the year ended December 31, 2025, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Media and Investor Relations Contact Courtney O'Konek Vice President, Corporate Communications Olema Oncology [email protected] This is a paid placement. For further inquiries, please contact GlobeNewswire directly.