Senior QA Systems Specialist: GxP Compliance & Improvement

Neurocrine Biosciences; San Diego (CA); On-site; USD 97,000 - 133,000; Full time

Benefits offered by this job

Retirement plan

Paid vacation

Holiday leave

Parental/maternity leave

Health benefits

Job summary

Neurocrine Biosciences is seeking a QA professional to drive quality systems in a GxP environment. You will lead complex QA activities, coordinate audits, and enhance document control and LMS processes.

You will analyze QA data, generate metrics, and partner with cross-functional teams to ensure compliance with FDA, ICH and GMP standards. A strong mentorship role and process improvement focus are expected.

Qualifications

• Bachelor’s degree in a relevant field with 4+ years in pharmaceutical/biotech QA activities.
• Strong verbal and written communication with cross-functional influence.
• Advanced proficiency with standard computer applications and systems.
• Knowledge of regulatory requirements and industry standards (FDA, ICH, GxP, GMP, GLP, GCP).
• Experience supporting audits and inspections, including prep, coordination and response support.

Responsibilities

• Independently perform and coordinate complex QA activities, including document control, LMS administration, vendor management and audits.
• Ensure accuracy, completeness, and traceability of QA records through data entry, document processing and reconciliation.
• Support and enhance electronic quality systems, including user support and system documentation.
• Review and process controlled documents, lead revision of SOPs and work instructions for compliance.
• Support inspection and audit readiness activities and coordination of backroom/inspection room support.
• Generate and analyze QA reports, metrics and dashboards to support performance monitoring.
• Collaborate with cross-functional stakeholders to meet GxP requirements and company policies.
• Identify, assess and elevate quality issues; support investigations and CAPA.
• Lead process improvement initiatives within the functional area.
• Provide guidance and mentorship to junior staff on quality systems and documentation.
• Apply sound judgment to resolve complex issues and escalate as needed.

Skills

Quality systems

GxP compliance

Data analysis

Regulatory knowledge

Cross-functional collaboration

Leadership

Mentorship

Problem solving

Documentation

Training

Education

Bachelor’s degree in related field

Master’s degree

Tools

QMS administration

LMS administration

Document control software

Job description

Neurocrine Biosciences is seeking a QA professional to drive quality systems in a GxP environment. You will lead complex QA activities, coordinate audits, and enhance document control and LMS processes.

You will analyze QA data, generate metrics, and partner with cross-functional teams to ensure compliance with FDA, ICH and GMP standards. A strong mentorship role and process improvement focus are expected.