Associate Director, GMP Quality

Olema Oncology • San Francisco, CA

10d • Hybrid

About The Position

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. It’s an exciting time to be part of Team Olema, with our transformation into a fully integrated oncology company well underway, top-line data from our lead program expected later this year, and our first potential commercial launch on the horizon. Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in the fall which, if successful, could lead to our first potential approval and commercial launch in 2027. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant has the potential to transform the metastatic breast cancer treatment paradigm and access a $15 billion global market opportunity. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape – particularly in combination with palazestrant. We recently reported encouraging Phase 1 monotherapy data from this program across multiple solid tumor types and are advancing patient enrollment in the ongoing combination arms in MBC. Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and a passionate team dedicated to helping the patients we serve feel better, longer. We possess a deep commitment to our shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. Team Olema is made up of nimble self-starters who bring consistency in their quest for the extraordinary every single day. If you’re ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – for our patients, for your career, and for what’s beyond. About the Role >>> Associate Director GMP Quality As the Associate Director, GMP Quality, reporting to the Head of GMP Quality, you will be responsible for oversight of GMP activities pertaining to Olema’s products, both clinical and commercial. The focus of this role will be oversight of the manufacture of small molecule drug substances (Active Pharmaceutical Ingredients). There will be associated responsibilities for reviewing Analytical Development / Quality Control results. In this position you will perform GMP activities such as, but not limited to, review of Certificate of Analysis, Batch Disposition, Person in Plant oversight, and supporting Supplier compliance. In this role you will also collaborate with other functional teams such CMC, Regulatory and Supply Chain to prepare submissions, ensure quality and compliance for Olema’s products. This role will be based out of our San Francisco or Boston office and will require 10-15% travel, some international.

Requirements

• Bachelor’s degree is required; advanced degree (MS, PharmD, PhD) preferred
• Extensive understanding and knowledge of industry standards, concepts and current cGMP (21 CFR Parts 210 and 211), EudraLex Volume 4, ICH Q7 and other agency standards and guidance as they relate to GMP Quality Assurance
• Minimum of 8 years' work experience in an FDA regulated Pharmaceutical GMP / GMP QA role
• Experience with small molecule synthesis and analytical test record review
• Prior experience with NDA/BLA submission and commercial launch for pharmaceutical products
• Familiarity with effective Quality Systems and performing robust investigations
• Experience with Health Authority filings and EU QP queries
• Experience managing CMO relationships and supporting CMO inspections
• Experience with Quality Management Systems such as Veeva or TrackWise
• Proficient in Word, Excel, PowerPoint, SharePoint
• Demonstrated proven track record of leadership, communication, adaptability, and collaboration
• Communicate decisions and recommendations with clear background and justification
• A strong team player with the ability to focus on project objectives with an emphasis on quality
• Clear, concise writing skills and good verbal presentation skills
• Ability to prioritize, work independently, and mindfully engage with others

Nice To Haves

• Advanced degree (MS, PharmD, PhD) preferred

Responsibilities

• Batch disposition/ release for Clinical Trial Materials and Commercial batches
• Perform technical review, quality oversight and approvals Master Batch records and Executed Batch records
• Review and approval of CMO Deviations, CAPA, and Change Controls and opening of internal shadow records when required
• Perform technical review of Quality Control records such as Certificate of Analysis, Analytical Testing, Method Validation and Stability reports
• Operational oversight of Olema’s CMOs as specified in quality agreements; this may include periodic visits to CMOs
• Represent Olema as Person in Plant (PIP) when critical processing occurs as necessary
• Support Pre-Approval Inspection readiness for NDA / commercial launch
• Review sections of New Drug Applications for content and accuracy
• Review Quality Agreements and support Supplier audits as necessary
• Interact with Qualified Persons (QP) to facilitate the release of Clinical and Commercial product
• Generate metrics for Quality Management Reviews
• Contribute and participate in Annual Product Quality Reviews of commercial products
• Represent GMP Quality during internal and regulatory inspections
• Author Quality department SOPs as required

Benefits

• equity
• bonus
• competitive compensation and benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Manager