GxP Quality Systems Lead (QA & Compliance)

Scorpion Therapeutics; Carlsbad (CA); On-site; USD 71,000 - 102,000; Full time

Job summary

Ionis is seeking a Manager / QA Associate, GxP Quality Systems, to support compliance across Ionis quality systems. The role involves planning, execution, and oversight of GMP and GxP quality assurance activities in line with regulatory requirements.

You will drive QMS metrics, lead cross-functional quality initiatives, and support inspection readiness and audits. The position requires a Bachelor's degree in a science-related field and 3+ years of QA experience, with strong understanding of

Qualifications

• Bachelor’s degree in a science-related discipline.
• 3+ years of QA experience.
• Solid understanding of pharma/biotech quality systems.
• Familiar with AI applications in GxP QA (desirable).

Responsibilities

• Support QMS processes to align with GMP/GxP and regulatory requirements.
• Generate, trend, and present QMS metrics for risk identification.
• Lead cross-functional initiatives to improve quality system compliance.
• Assist in inspection readiness and audit activities.
• Support vendor management and internal audits.

Skills

QA experience

GxP knowledge

Regulatory compliance

Communication skills

Education

Bachelor’s degree

Job description

Ionis is seeking a Manager / QA Associate, GxP Quality Systems, to support compliance across Ionis quality systems. The role involves planning, execution, and oversight of GMP and GxP quality assurance activities in line with regulatory requirements.

You will drive QMS metrics, lead cross-functional quality initiatives, and support inspection readiness and audits. The position requires a Bachelor's degree in a science-related field and 3+ years of QA experience, with strong understanding of