Associate Director, External Quality (Biotech)

TL;DR

Associate Director, External Quality (Biotech): Providing quality oversight of Contract Manufacturing Operations (CMO) and material suppliers with an accent on GMP compliance, product disposition, and QMS management. Focus on ensuring manufacturing standards for CAR T cell products and managing regulatory inspections.

Location: Newark, CA (Onsite). Must be authorized to work in the U.S.

Salary: $170,000 – $210,000 per year

Company

A clinical-stage biotechnology company pioneering the development of allogeneic CAR T cell products for cancer and autoimmune diseases.

What you will do

• Provide quality leadership to meet technical and compliance requirements for CMOs and material suppliers.
• Oversee manufacturing and disposition of GMP starting materials, Drug Substance, and Drug Product.
• Manage quality agreements, change notifications, and CMO-initiated corrective actions.
• Lead regulatory health authority inspections and provide QA guidance on emerging trends.
• Execute QA programs, including auditing, SOP reviews, and manufacturing record audits.
• Drive continuous improvement using quality tools such as lean, six sigma, and risk management.

Requirements

• At least 7 years of experience in the bio-pharmaceutical field with manufacturing operations oversight.
• Bachelor’s degree in engineering, chemistry, or biological sciences.
• Extensive knowledge of US FDA GMP, EMA, and ICH guidelines.
• Proven track record of successfully leading regulatory inspections.
• Must be authorized to work in the United States.
• Proficiency in MS Office, Visio, Project, and statistical software.

Nice to have

• Advanced degree with training in cell culture and gene therapy.
• ASQ Auditor or Quality Engineer certification.

Culture & Benefits

• Top-notch compensation package including annual performance bonus and equity.
• Comprehensive health insurance.
• Generous time off, including two annual company-wide holiday shutdowns.
• Collaborative work environment with a talented team of specialists.