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About the Role

Olema Oncology is seeking an Associate Director, GMP Quality to oversee GMP activities for Olema’s clinical and commercial products, with a focus on small molecule drug substance manufacturing. This role involves reviewing analytical data, batch records, and supporting supplier compliance, while collaborating with CMC, Regulatory, and Supply Chain teams.

Responsibilities

• Oversee GMP activities pertaining to Olema’s products, both clinical and commercial.
• Oversee the manufacture of small molecule drug substances (Active Pharmaceutical Ingredients).
• Review Analytical Development / Quality Control results.
• Perform GMP activities such as review of Certificate of Analysis, Batch Disposition, Person in Plant oversight, and supporting Supplier compliance.
• Collaborate with CMC, Regulatory and Supply Chain teams to prepare submissions, ensure quality and compliance.
• Batch disposition/ release for Clinical Trial Materials and Commercial batches.
• Perform technical review, quality oversight and approvals of 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.
• Provide operational oversight of Olema’s CMOs as specified in quality agreements, including periodic visits.
• Represent Olema as Person in Plant (PIP) during critical processing.
• 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.
• Interact with Qualified Persons (QP) to facilitate the release of Clinical and Commercial product.
• Generate metrics for Quality Management Reviews.
• Contribute to and participate in Annual Product Quality Reviews of commercial products.
• Represent GMP Quality during internal and regulatory inspections.
• Author Quality department SOPs as required.

Requirements

• Bachelor’s degree required; advanced degree (MS, PharmD, PhD) preferred.
• Extensive understanding of industry standards, concepts, and current cGMP (21 CFR Parts 210 and 211), EudraLex Volume 4, ICH Q7 and other agency standards and guidance.
• 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 track record of leadership, communication, adaptability, and collaboration.
• Ability to communicate decisions and recommendations with clear background and justification.
• 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.

Skills

• GMP Quality Assurance
• Small molecule synthesis
• Analytical test record review
• NDA/BLA submission
• Commercial launch
• Quality Systems
• Investigations
• Health Authority filings
• EU QP queries
• CMO management
• CMO inspections
• Quality Management Systems (Veeva, TrackWise)
• Microsoft Office Suite (Word, Excel, PowerPoint)
• SharePoint
• Leadership
• Communication
• Adaptability
• Collaboration
• Prioritization
• Independent work
• Verbal presentation

Location

• San Francisco
• Boston

Work Type

• Full-time
• Hybrid

Experience Level

• Associate Director
• 8+ years

Education Level

• Bachelor's degree
• Advanced degree preferred (MS, PharmD, PhD)

Salary/Compensations

• $160,000 - $180,000 annually

Benefits

• Equity
• Bonus
• Competitive compensation and benefits package
• Open, flexible, and friendly work environment
• Platform for long-term career development

About the Company

• 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.
• We are transforming into a fully integrated oncology company with top-line data from our lead program expected soon and a 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) in Phase 3 trials.
• Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with potential to generate further value.
• 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.

Equal Opportunity

• We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience.
• Olema is building a culture where the value of difference is celebrated.