Manager/ QA Associate, GxP Quality Systems

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. Responsible for planning, execution, and oversight of GMP and GxP quality assurance activities and alignment with applicable domestic and international regulatory requirements, industry guidelines, and Ionis quality management system procedures.

Core Responsibilities

• Support QMS processes and workflows to ensure procedures, records, and practices align with regulatory requirements, GMP/GxP expectations, and Ionis policies/SOPs.
• Generate, trend, and present QMS metrics; identify compliance risks, performance gaps, and continuous improvement opportunities.
• Lead and participate in cross-functional initiatives to strengthen quality system compliance, effectiveness, inspection readiness, and operational efficiency.
• Support Quality Management Review activities (data collection/analysis, presentation materials, facilitation, action documentation, and follow-up).
• Support inspection readiness (coordination, review of inspection materials, response tracking, follow-up on commitments).
• Support vendor management (supplier/CMO/CTL audit support, internal audit activities, vendor change notifications).
• Support new quality initiatives and company-wide projects requiring QA partnership.
• Contribute to design and implementation of corporate quality and continuous improvement programs.

Requirements

• Bachelor’s degree in a science-related or other relevant discipline (required).
• Strong understanding of quality assurance/quality management with 3+ years relevant experience (required).
• Strong understanding of quality system guidelines and regulatory requirements for pharma/biotech (required).
• Familiarity with AI applications in a GxP quality assurance/quality systems environment (highly desirable).
• Strong customer orientation; written/verbal communication and pragmatic problem-solving skills (required).

Benefits

• The pay scale for this position is $70,844 to $102,371.