Associate Director, GMP Quality (Biopharmaceutical)

Location: Based out of the Boston or San Francisco office; requires 10–15% travel, including some international travel.

Salary: $160,000–$180,000 annually, plus equity, bonus, and benefits.

Company

hirify.global is a clinical-stage biopharmaceutical company developing therapies for metastatic breast cancer, including palazestrant and OP-3136.

What you will do

• Oversee GMP activities for clinical and commercial products, with a focus on small-molecule active pharmaceutical ingredients.
• Manage batch disposition and release for clinical trial materials and commercial batches.
• Review and approve master and executed batch records, Certificates of Analysis, analytical testing, method validation, and stability reports.
• Review CMO deviations, CAPAs, change controls, quality agreements, and supplier compliance activities.
• Provide operational oversight of CMOs, including periodic visits and Person in Plant support during critical processing.
• Support NDA and commercial-launch readiness, regulatory inspections, quality management reviews, and annual product quality reviews.

Requirements

• Bachelor’s degree required; an MS, PharmD, or PhD is preferred.
• Extensive knowledge of current cGMP requirements, including 21 CFR Parts 210 and 211, EudraLex Volume 4, and ICH Q7.
• Minimum of 8 years of experience in an FDA-regulated pharmaceutical GMP or GMP QA role.
• Experience with small-molecule synthesis, analytical test-record review, NDA/BLA submissions, and commercial launches.
• Experience with quality systems, investigations, CMO relationships, CMO inspections, Health Authority filings, and EU QP queries.
• Proficiency with Veeva or TrackWise and Microsoft Word, Excel, PowerPoint, and SharePoint.

Culture & Benefits

• Equal opportunity workplace with an emphasis on diverse expertise, backgrounds, and experience.
• Open, flexible, and friendly work environment.
• Competitive compensation and benefits package.
• Equity and bonus eligibility.
• Opportunities to develop a long-term career in a growing oncology company.