Manager/ Senior QA Associate, GxP Quality Systems

Ionis•Carlsbad, CA

1d•Hybrid

About The Position

Ionis is seeking a Manager / Senior QA Associate, GxP Quality Systems, to support compliance across Ionis quality systems. This role is responsible for supporting the planning, execution, and oversight of GMP and GxP quality assurance activities and ensuring alignment with applicable domestic and international regulatory requirements, industry guidelines, and Ionis quality management system procedures.

Requirements

Bachelor’s degree in a science-related or other relevant discipline required.
Strong understanding of quality assurance and quality management, with 3+ years of relevant experience required.
Strong understanding of quality systems guidelines and regulatory requirements applicable to the pharmaceutical or biotechnology industry required.
Strong customer orientation, written and verbal communication skills, and pragmatic problem-solving skills required.

Nice To Haves

Familiarity with artificial intelligence applications in a GxP quality assurance or quality systems environment is highly desirable.

Responsibilities

Support QMS processes and workflows to ensure procedures, records, and practices remain aligned with applicable regulatory requirements, GMP and GxP expectations, and Ionis policies and SOPs.
Generate, trend, and present QMS metrics to management and cross-functional stakeholders; identify compliance risks, performance gaps, and continuous improvement opportunities.
Lead and participate in cross-functional initiatives that strengthen quality system compliance, effectiveness, inspection readiness, and operational efficiency.
Support Quality Management Review activities, including data collection and analysis, development of presentation materials, facilitation support, documentation of actions, and follow-up on commitments.
Support inspection readiness activities, including coordination of preparation efforts, review of inspection support materials, response tracking, and follow-up on regulatory commitments.
Support execution of the vendor management program, including supplier, CMO, and CTL audit support, internal audit activities, and vendor change notifications.
Support new quality initiatives and company-wide projects that require significant QA partnership and resources.
Contribute to the design and implementation of corporate quality and continuous improvement programs.