Executive Director, GMP Quality (Biotech)

Location: Onsite in Carlsbad, California, United States

Salary: $221,151–$288,783 annually

Company

A pharmaceutical and biotechnology organization developing RNA-targeted medicines, gene-editing approaches, and therapies for serious diseases.

What you will do

• Provide strategic GMP Quality leadership for the Carlsbad campus, Faraday facility, and products manufactured internally or through CMOs.
• Lead GMP Quality processes covering clinical supply, drug substance and drug product manufacturing, testing, and release.
• Provide senior QA guidance on deviations, investigations, CAPAs, change controls, OOS/OOT results, and other GMP matters.
• Manage Quality relationships with CMOs, business partners, Technical Operations, Manufacturing, QC, Regulatory, and senior leadership.
• Lead audit and inspection readiness activities, develop responses to health authority observations, and represent QA during Faraday inspections.
• Develop Quality policies, procedures, programs, and training that support consistent GMP standards.

Requirements

• 20+ years of QA, GMP Quality, or compliance experience, including 10+ years of senior leadership in pharmaceutical or biotechnology manufacturing.
• Experience with regulatory inspections, audits, investigations, CAPA, change control, risk management, and US/global GMP requirements.
• Required experience with biologics and drug substance and/or drug product manufacturing.
• Strong senior-level leadership, communication, stakeholder management, influencing, prioritization, and risk management skills.
• Ability to lead cross-functional initiatives, coach and mentor colleagues, and drive compliant, sustainable improvements.

Nice to have

• Degree in a relevant scientific, engineering, pharmacy, or related discipline.
• Experience with aseptic products, combination products, or other complex pharmaceutical operations.

Culture & Benefits

• Environment focused on innovation, scientific excellence, and meaningful impact on patients.
• Opportunities to work across internal operations, external service providers, and international regulatory stakeholders.
• Excellent benefits package.