Director, External Quality (Biotech)

TL;DR

Director, External Quality (Biotech): Leading the Quality Assurance function for CMO oversight and supplier quality management with an accent on GMP compliance and regulatory standards. Focus on managing the disposition of GMP products, optimizing supplier quality systems, and ensuring alignment with US FDA and EMA guidelines.

Location: Hybrid in South San Francisco or Newark, CA. Must be authorized to work in the U.S.

Salary: $200,000–$230,000 per year

Company

hirify.global is a clinical-stage biotechnology company pioneering allogeneic CAR T cell products for cancer and autoimmune diseases.

What you will do

• Lead the QA function for Contract Manufacturing Operations (CMO) oversight and Supplier Quality Management (SQM).
• Manage the disposition of GMP starting materials, drug substance, drug product, and packaged/labeled products.
• Oversee quality for material suppliers, including media, chemicals, excipients, and packaging components.
• Collaborate with Manufacturing, Supply Chain, and CMC Program Management to ensure on-time delivery of approved products.
• Negotiate Quality Agreement terms and represent the Quality function in CMC product development teams.
• Drive continuous improvement utilizing quality tools such as lean, six sigma, and risk management.

Requirements

• Bachelor’s degree in Engineering, Chemistry, or biological sciences (advanced degree preferred).
• 12+ years of experience in manufacturing, QA, QC, or quality engineering in bio-pharmaceuticals or medical devices.
• Minimum 5 years in a related management role.
• Extensive working knowledge of US FDA GMP, EMA, and ICH guidelines.
• Must be authorized to work in the U.S.
• Ability to travel up to 10%.

Culture & Benefits

• Collaborative work environment with high-performing teams.
• Competitive compensation package including an annual performance bonus and equity.
• Comprehensive health insurance.
• Generous time off, including two annual company-wide holiday shutdowns.