Executive Director, GMP Quality — Global QA Leader

Ionis Brand; Marana (AZ); On-site; USD 221,000 - 289,000; Full time

Job summary

Ionis Pharmaceuticals, Inc. is seeking an Executive Director, GMP Quality to provide strategic leadership for GMP Quality activities across the Carlsbad campus and external sites. The role leads QA operations, regulatory inspections readiness, and collaboration with CMOs to ensure compliant, high-quality drug substance and product manufacturing. The candidate will guide risk management and continuous quality improvements.

Qualifications

• 20+ years in QA, GMP Quality, or compliance
• 10+ years in senior leadership building a QA organization
• Experience with regulatory inspections, audits, CAPA, change control
• Experience with biologics, drug substance/product manufacturing
• Strong stakeholder management and cross-functional leadership
• Proven ability to lead quality improvements and ensure regulatory compliance

Responsibilities

• Provide strategic leadership for GMP Quality across Carlsbad and external sites
• Oversee GMP compliance for clinical and commercial supply
• Lead audits and inspections readiness and responses to health authority observations
• Develop and enhance Quality policies, programs, and training
• Manage relationships with CMOs and Ionis leadership
• Support risk management and continuous improvement initiatives

Skills

Senior leadership

GMP compliance

Regulatory inspections

Quality strategy

Cross-functional leadership

Quality culture

Risk management

Education

Science/Engineering/Pharmacy degree

Advanced degree preferred

Tools

ICH guidelines

CQA/QA systems

Job description

Ionis Pharmaceuticals, Inc. is seeking an Executive Director, GMP Quality to provide strategic leadership for GMP Quality activities across the Carlsbad campus and external sites. The role leads QA operations, regulatory inspections readiness, and collaboration with CMOs to ensure compliant, high-quality drug substance and product manufacturing. The candidate will guide risk management and continuous quality improvements.