GMP Quality Executive Director — Onsite Lead

Ionis-Pharmaceuticals; Carlsbad (CA); On-site; USD 221,000 - 289,000; Full time

Job summary

Ionis Pharmaceuticals, Inc. seeks an Executive Director, GMP Quality to lead the Carlsbad campus quality organization and oversee GMP activities across drug substance and product lifecycle, including CMOs and regulatory inspections.

This senior role reports to the VP of GMP Quality and drives quality excellence across global operations. The role emphasizes strategic leadership of GMP Quality programs, risk management, and continuous improvement, with accountability for inspections and

Qualifications

• Minimum of 20 years of QA, GMP Quality, or compliance experience.
• 10+ years of senior leadership experience building and developing a Quality organization in a pharmaceutical or biotech setting.
• Experience with regulatory inspections, audits, investigations, CAPA, change control, risk management, and USA/global GMP requirements.
• Experience with biologics and drug substance/product manufacturing.

Responsibilities

• Provide strategic leadership for GMP Quality activities supporting Carlsbad, Faraday, and related development lifecycle products.
• Lead establishment and enhancement of GMP Quality processes for clinical supply, drug substance and drug product manufacturing, testing, and release.
• Provide senior QA expertise and strategic guidance on quality issues, investigations, CAPAs, change controls, and GMP matters.
• Lead relationships with CMOs, partners, and internal teams to support risk management and continuous improvement.
• Lead audit and inspection readiness and responses to health authority observations; serve as lead QA representative during inspections.
• Develop and enhance Quality policies, programs, procedures, and training to align with Ionis objectives.

Skills

Senior leadership

Quality strategy

Stakeholder management

Cross-functional leadership

Regulatory interaction

Education

Bachelor's degree in a scientific field

Job description

Ionis Pharmaceuticals, Inc. seeks an Executive Director, GMP Quality to lead the Carlsbad campus quality organization and oversee GMP activities across drug substance and product lifecycle, including CMOs and regulatory inspections.

This senior role reports to the VP of GMP Quality and drives quality excellence across global operations. The role emphasizes strategic leadership of GMP Quality programs, risk management, and continuous improvement, with accountability for inspections and