Sr. Specialist, QA Systems
Neurocrine Biosciences · San Diego, CA
QualityFull-time$97k–$133kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Neurocrine Biosciences seeks a Senior Specialist in QA Systems to manage complex quality assurance activities and enhance compliance processes within a GxP-regulated biopharmaceutical environment. The role involves executing quality systems, supporting regulatory readiness, and driving continuous improvement initiatives while mentoring junior staff.
What they're looking for
- Bachelor's degree in relevant field plus 4+ years pharmaceutical/biotech QA experience, OR Master's degree plus 2+ years relevant experience
- Strong knowledge of quality systems and GxP compliance processes (deviations, CAPA, change control, document control, supplier quality)
- Advanced proficiency with electronic quality systems (QMS, LMS) including administration and process improvement
- Demonstrated understanding of regulatory requirements (FDA, ICH, GxP, GMP, GLP, GCP) and industry standards
- Strong written and verbal communication skills with ability to influence cross-functional stakeholders
- Excellent organizational and analytical skills with ability to manage multiple competing priorities
- Demonstrated leadership capability with ability to mentor junior team members
What you'll be doing
- Execute and coordinate complex quality systems activities including document control, vendor management, investigations, complaints, and CAPA
- Ensure accuracy and traceability of QA records through oversight of data entry, processing, and reconciliation
- Support and enhance electronic quality systems through user support, documentation, and implementation of improvements
- Generate, analyze, and interpret quality metrics, reports, and dashboards to support performance monitoring and management review
- Lead process improvement efforts and support inspection and audit readiness activities including coordination and follow-up
Privacy & handoff
This role links to Neurocrine Biosciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.