Executive Director, GMP Quality

Scorpion Therapeutics; Carlsbad (CA); On-site; USD 210,000 - 270,000; Full time

Job summary

Ionis is seeking a Senior GMP Quality leader to oversee quality operations at the Carlsbad campus and Faraday facility, supporting drug development through commercial manufacturing. You will provide strategic direction on GMP processes for both drug substance and product, and lead a team across QA, compliance, and manufacturing.

The role requires deep experience in biologics, regulatory inspections, CAPAs, and risk management, with a track record of audit readiness and global regulatory liaison.

Qualifications

• 20+ years in GMP Quality or compliance, with 10+ years in senior biotech/pharma leadership.
• Experience in biologics, drug substance, and complex pharmaceutical operations.
• Strong expertise in regulatory inspections, investigations, CAPAs, and risk management.

Responsibilities

• Provide strategic direction on GMP processes for drug substance and product.
• Ensure compliance with global regulations (FDA, EU, MHLW, TGA).
• Lead audit and inspection readiness.
• Manage relationships with CMOs and internal teams.

Skills

GMP leadership

Quality systems

Audit readiness

Cross-functional leadership

Education

Bachelor's degree in Science or Engineering

Tools

CAPA systems

Quality management software

Job description

Senior GMP Quality leader overseeing quality operations at Ionis' Carlsbad campus and Faraday facility, supporting drug development through commercial manufacturing.

Responsibilities

• provide strategic direction on GMP processes for drug substance and product.
• ensure compliance with global regulations (FDA, EU, MHLW, TGA).
• lead audit and inspection readiness.
• manage relationships with CMOs and internal teams.

Requirements

• minimum 20 years in GMP Quality or compliance, with 10+ years in senior leadership roles in biotech/pharma manufacturing.
• experience in biologics, drug substance, and complex pharmaceutical operations.
• strong expertise in regulatory inspections, investigations, CAPAs, and risk management.
• degree in scientific or engineering discipline preferred.

WorkSetup: onsite in Carlsbad, CA.