Associate Director, Development QA & Inspections

Ionis Pharmaceuticals, Inc.; Carlsbad (CA); On-site; USD 154,500 - 196,873; Full time

Benefits offered by this job

Health benefits

Flexible work environments

401(k) plan

Job summary

Ionis Pharmaceuticals, Inc. in Carlsbad, California is seeking an Associate Director for Development Quality Assurance. This leader will manage GCP audits and ensure compliance with international regulations while overseeing inspection readiness and quality oversight during clinical trials.

Candidates should have significant experience in GCP quality assurance, along with strong organizational and communication skills. This full-time position offers an excellent opportunity to impact patient health and works within a collaborative environment focused on innovation.

Qualifications

• Minimum 12 years of GCP quality assurance experience or equivalent.
• Thorough understanding of ICH Guidelines and GCP regulatory requirements.
• Effective verbal and written communication skills.

Responsibilities

• Lead, conduct, and coordinate GCP-related audits.
• Prepare for and manage Health Authority inspections.
• Provide quality oversight and consultation during clinical trials.

Skills

GCP quality assurance experience

Clinical development process understanding

Risk management

Effective communication

Interpersonal skills

Organizational skills

Education

Bachelor's degree with 12 years of experience or Master's with 8 years

PhD with 5 years of relevant experience

Tools

Computer System Validation knowledge

Job description

Ionis Pharmaceuticals, Inc. in Carlsbad, California is seeking an Associate Director for Development Quality Assurance. This leader will manage GCP audits and ensure compliance with international regulations while overseeing inspection readiness and quality oversight during clinical trials.

Candidates should have significant experience in GCP quality assurance, along with strong organizational and communication skills. This full-time position offers an excellent opportunity to impact patient health and works within a collaborative environment focused on innovation.