Quality Systems Specialist - GxP Compliance & QA

Neurocrine Biosciences; San Diego (CA); On-site; USD 77,000 - 105,000; Full time

Benefits offered by this job

Annual bonus

Equity opportunity

Comprehensive benefits

Retirement plan with company match

Paid vacation

Holidays and personal days

Parental and medical leave

Health benefits (medical/dental/vision

Job summary

Neurocrine Biosciences in San Diego, CA, seeks a Quality Systems Specialist to support GxP-regulated quality processes, document control, LMS administration and CAPA activities, and to ensure data integrity across QA operations. You’ll collaborate with cross-functional partners, maintain regulatory readiness for audits, and contribute to continuous improvement initiatives.

A BS/BA in a life sciences field with 6+ years of QA/GxP experience, or a Master’s with relevant background, is preferred.

Qualifications

• 6+ years of QA experience in a GxP environment.
• BS/BA in Chemistry, Biology, or related field; Master’s preferred.
• Strong written and verbal communication skills.
• Knowledge of FDA, ICH, GMP, GLP, and GCP regulations.

Responsibilities

• Perform day-to-day quality systems activities, including document control and deviations.
• Manage LMS administration and vendor-related processes.
• Support CAPA, SCAR, and change control activities.
• Review documents for formatting, completeness, and compliance.
• Assist with audit readiness and inspection support.
• Generate reports and dashboards to monitor QA metrics.
• Collaborate with cross-functional teams to ensure GxP compliance.

Skills

Quality systems

GxP compliance

Document control

LMS administration

CAPA and deviations

Change control

Data integrity

Cross-functional collaboration

Regulatory knowledge

Communication skills

Education

BS/BA in life sciences

MS in life sciences (preferred)

Tools

QMS

LMS

Job description

Neurocrine Biosciences in San Diego, CA, seeks a Quality Systems Specialist to support GxP-regulated quality processes, document control, LMS administration and CAPA activities, and to ensure data integrity across QA operations. You’ll collaborate with cross-functional partners, maintain regulatory readiness for audits, and contribute to continuous improvement initiatives.

A BS/BA in a life sciences field with 6+ years of QA/GxP experience, or a Master’s with relevant background, is preferred.