Quality Systems Specialist

Job Description

Sr. Specialist, QA Systems | Neurocrine Biosciences

The Tone:
This is a full-time role at Neurocrine Biosciences, located in San Diego, California, USA. Neurocrine Biosciences is a biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with neurological, psychiatric, endocrine, and immunological disorders. This role is crucial for ensuring that all quality systems and compliance activities within a GxP-regulated environment are executed effectively and in adherence to regulatory requirements. The Senior Specialist will apply advanced knowledge to enhance processes, systems, and data quality within the Quality Management System, directly contributing to the company’s mission of relieving suffering for people with great needs.

The TL;DR
• Role: Full Time
• Type: Full-time
• Location: In-person – San Diego, California, USA
• Pay: $97000–$133000 yearly
• Mission: This person ensures quality systems and processes comply with internal procedures and regulatory requirements in a GxP-regulated environment.
• Tech Stack: QMS, LMS, standard computer applications

What You’ll Actually Do
• Quality System Operations: Independently manage and coordinate complex quality system activities, including document control, LMS administration, vendor management, investigations, product complaints, change control, CAPA, SCAR, and deviations.
• Compliance and Documentation: Ensure the accuracy, completeness, and traceability of all QA records, and lead the review and revision of controlled documents like SOPs and work instructions to maintain compliance.
• Electronic System Support: Provide comprehensive support for electronic quality systems, including user assistance, system documentation, and implementing process improvements within your functional area.
• Audit Readiness: Coordinate and execute inspection and audit readiness activities, offering essential back room and inspection room support, along with necessary follow-up actions.
• Data Analysis and Improvement: Generate, analyze, and interpret quality reports, metrics, and dashboards to monitor QA performance, assess data integrity, and lead discrete process improvement efforts.

The Must-Haves
• Background: Bachelor’s degree from an accredited college or university in a relevant field or a Master’s degree. This includes foundational knowledge for managing quality assurance activities in a GxP environment.
• Experience: Minimum of 4 years of experience in the pharmaceutical or biotech industry (or 2 years with a Master’s degree) directly managing quality assurance activities such as training, change control, investigations, and other quality systems. Proven experience with electronic quality systems (QMS, LMS), including administration, user support, and process enhancement, along with supporting audits and inspections.
• Skills: Strong knowledge of GxP quality systems (deviations, CAPA, change control, document control, supplier quality, product complaints) and regulatory requirements and industry standards (FDA, ICH, GMP, GLP, GCP). Excellent verbal and written communication, organizational, planning, and critical thinking skills. Proficiency with standard computer applications, electronic quality systems, documentation practices, and data integrity principles.
• Bonus: Demonstrated leadership in leading initiatives and providing mentorship to less experienced team members. Proven ability to identify process improvement opportunities, implement enhancements, and analyze quality data and trends for informed decision-making.