Senior Director, GMP Quality & Compliance

Ionis Pharmaceuticals, Inc.; Carlsbad, Northern (CA, KY); Hybrid; USD 221,000 - 289,000; Full time

Job summary

Ionis Pharmaceuticals, Inc. is seeking an Executive Director, GMP Quality to lead GMP Quality activities for the Carlsbad campus and Faraday facility.

The role includes strategic direction for QA, oversight of clinical and commercial manufacturing, and management of inspections with internal teams and CMOs. The position reports to the Vice President of GMP Quality and requires extensive experience in FDA/global GMP, with a strong track record in building high-performing QA groups and driving

Qualifications

• 20+ years in QA, GMP Quality, or compliance in pharma/biotech manufacturing.
• 10+ years in senior leadership building a Quality organization.

Responsibilities

• Provide strategic leadership for GMP Quality at Carlsbad and Faraday facilities and CMOs.
• Oversee GMP quality activities across clinical and commercial supply, including inspections.
• Lead audit readiness and responses to health authority observations.
• Develop and enhance quality policies, programs, and training.
• Interface with CMOs, operations, regulatory, and leadership to manage risk and drive improvements.

Skills

Regulatory audits

QA leadership

GMP compliance

Risk management

Stakeholder management

Cross-functional collaboration

Education

Relevant science/engineering degree

Job description

Ionis Pharmaceuticals, Inc. is seeking an Executive Director, GMP Quality to lead GMP Quality activities for the Carlsbad campus and Faraday facility.

The role includes strategic direction for QA, oversight of clinical and commercial manufacturing, and management of inspections with internal teams and CMOs. The position reports to the Vice President of GMP Quality and requires extensive experience in FDA/global GMP, with a strong track record in building high-performing QA groups and driving