Associate Director, GMP Quality

Olema Oncology•Boston, MA

2h•$160,000 - $180,000•Hybrid

About The Position

Olema Oncology is a clinical-stage biopharmaceutical company focused on transforming the standard of care for patients with breast cancer. The company is undergoing a significant transformation into a fully integrated oncology company, with key data expected for its lead program and a potential commercial launch on the horizon. Their lead product candidate, palazestrant, is an oral estrogen receptor antagonist and degrader in Phase 3 trials. A follow-on candidate, OP-3136, is a KAT6 inhibitor. Olema emphasizes a resolute approach, a passionate team, and a culture of excellence, courage, drive, adaptability, learning, growth, and evolution. They seek nimble self-starters who consistently strive for the extraordinary. This role is for an Associate Director, GMP Quality, reporting to the Head of GMP Quality, responsible for overseeing GMP activities for Olema’s clinical and commercial products, with a primary focus on small molecule drug substance manufacturing. Responsibilities include reviewing analytical data, batch disposition, person-in-plant oversight, and supporting supplier compliance. The role also involves collaboration with CMC, Regulatory, and Supply Chain teams for submissions and ensuring product quality and compliance. The position is based in San Francisco or Boston and requires 10-15% travel, including some international travel.

Requirements

Bachelor’s degree is required
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