Associate Director, GMP Quality

Olema Oncology; Boston (MA); On-site; USD 160,000 - 180,000; Full time

Job summary

Olema Oncology seeks an Associate Director GMP Quality to oversee GMP activities for clinical and commercial products, focusing on small molecule drug substances. You will review analytical development and QC results, COAs, batch disposition, and support supplier compliance.

Based in San Francisco or Boston with 10–15% travel, the role partners with CMC, Regulatory, and Supply Chain teams to prepare submissions, ensure quality, and represent GMP Quality during inspections.

Qualifications

• 8+ years in FDA-regulated pharmaceutical GMP QA roles.
• Experience with NDA/BLA submissions and commercial launches.
• Experience with CMO management and inspections.
• Familiarity with quality systems and robust investigations.
• Experience with health authority filings and EU QP queries.
• Proficiency in MS Office Suite.

Responsibilities

• Batch disposition and release for clinical and commercial batches.
• Technical review of master and executed batch records for quality and compliance.
• Oversee CMO deviations, CAPA, and change controls; open shadow records when required.
• Technical review of COA, testing, method validation, and stability reports.
• Oversee CMOs operations and periodic visits; act as PIP when needed.
• Support NDA/pre-approval inspection readiness and document readiness.

Skills

Leadership

Communication

Collaboration

Quality assurance

GMP knowledge

Regulatory awareness

Education

Bachelor’s degree; advanced degree preferred

Tools

Veeva

TrackWise

Word

Excel

PowerPoint

SharePoint

Job description

Associate Director GMP Quality

Reporting to the Head of GMP Quality, you will oversee GMP activities related to Olema’s clinical and commercial products, with a focus on the manufacture of small molecule drug substances (Active Pharmaceutical Ingredients). Responsibilities include reviewing analytical development and quality control results, Certificate of Analysis, batch disposition, and supporting supplier compliance. You will collaborate with CMC, Regulatory, and Supply Chain teams to prepare submissions, ensure quality and compliance, and represent Olema’s GMP Quality during internal and regulatory inspections.

This role will be based out of our San Francisco or Boston office and will require 10‑15% travel, including some international travel.

Your work will primarily encompass

• Batch disposition and release for clinical trial materials and commercial batches
• 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
• 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, including periodic visits
• Represent Olema as Person in Plant (PIP) when critical processing occurs
• 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 needed
• 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

Ideal Candidate Profile — Key Requirements

Knowledge

• 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 relevant to GMP Quality Assurance

Experience

• 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
• Proficiency in Word, Excel, PowerPoint, SharePoint

Attributes

• Demonstrated proven track record of leadership, communication, adaptability, and collaboration
• Capable of communicating 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 engage mindfully with others

The base pay range for this position is expected to be $160,000 - $180,000 annually; the offer may vary based on location, market, experience, and other factors. The total compensation package also includes equity, bonus, and benefits.

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.

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A summary of benefits is available for all applicants.