Associate Director, GMP Quality (Biopharmaceutical)

Location: Based out of the San Francisco or Boston 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 breast cancer, including the palazestrant and OP-3136 programs.

What you will do

• Oversee GMP activities for clinical and commercial products, focusing on small-molecule drug substances and active pharmaceutical ingredients.
• Release clinical trial materials and commercial batches, including batch disposition and review of master and executed batch records.
• Review and approve CMO deviations, CAPAs, change controls, certificates of analysis, analytical testing, method validation, and stability reports.
• Provide operational oversight of CMOs, conduct person-in-plant activities, support supplier compliance, and participate in supplier audits.
• Support pre-approval inspection readiness, NDA submissions, regulatory inspections, annual product quality reviews, and quality management reviews.
• Collaborate with CMC, Regulatory, Supply Chain, Qualified Persons, and other functions; author GMP quality SOPs as needed.

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, ICH Q7, and related agency guidance.
• At least 8 years of experience in an FDA-regulated pharmaceutical GMP or GMP QA role.
• Experience with small-molecule synthesis, analytical record review, NDA/BLA submissions, commercial launches, health authority filings, and EU QP queries.
• Experience managing CMO relationships, supporting CMO inspections, and conducting robust investigations within effective quality systems.
• Experience with Veeva or TrackWise and proficiency in Word, Excel, PowerPoint, and SharePoint.

Culture & Benefits

• Work in a collaborative, adaptable, and quality-focused biopharmaceutical environment.
• Competitive compensation and benefits package with equity and bonus eligibility.
• Open, flexible, and friendly work environment supporting long-term career development.
• Equal opportunity workplace that values diverse expertise, backgrounds, and experience.