Manager/ Senior QA Associate, GxP Quality Systems
$70,844–$102,371 year
On-siteCarlsbad, California, United States
Job Summary
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. Contribute to the design and implementation of corporate quality and continuous improvement programs.
Required Qualifications
- Bachelor's degree in a science-related or other relevant discipline
- Strong understanding of quality assurance and quality management
- 3+ years of relevant experience
- Strong understanding of quality systems guidelines and regulatory requirements applicable to the pharmaceutical or biotechnology industry
- Strong customer orientation
- Written and verbal communication skills
- Pragmatic problem-solving skills
Desired Qualifications
- Familiarity with artificial intelligence applications in a GxP quality assurance or quality systems environment
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