Specialist, QA Systems

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.
• Demonstrated problem-solving and analytical skills, with the ability to exercise judgment within defined procedures
• Ability to work effectively both independently and as part of a team
• Proficiency with standard computer applications and systems
• Ability to apply company policies and procedures to resolve routine to moderately complex issues
• Working knowledge of quality systems and compliance processes within a GxP-regulated environment (e.g., deviations, CAPA, change control, document control, training, supplier quality, product complaints)
• Understanding of applicable regulatory requirements and industry standards (e.g., FDA, ICH, GxP, GMP, GLP, GCP)
• Experience supporting electronic quality systems (e.g., QMS, LMS) including data entry, record maintenance, and basic system support
• Knowledge of documentation practices and requirements to ensure accuracy, completeness, and traceability of QA records
• Familiarity with audit and inspection support activities, including document retrieval and tracking
• Ability to generate and interpret standard QA reports, metrics, and dashboards to support monitoring and review

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.
• Collaborate with cross-functional stakeholders to support project deliverables and ensure compliance with GxP requirements and company policies
• Identify and communicate quality or compliance issues within defined processes; escalates and support follow-up actions and resolution
• Support continuous improvement initiatives by identifying opportunities and assisting with implementation within defined scope
• Maintain working knowledge of applicable GxP regulations, internal procedures, and industry standards
• Perform other QA-related duties, as assigned

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

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid-to-late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

About the Role:

Supports the execution and maintenance of quality systems and compliance processes within a GxP-regulated environment. Performs moderately complex activities with general supervision, applying established procedures and sound judgment to ensure quality systems and related processes (e.g., deviations, change control, vendor management, product complaints, document control) remain compliant with internal standards and regulatory requirements. Contributes to the effectiveness of the Quality Management System (QMS) by supporting process improvements, maintaining data integrity, and collaborating with cross-functional partners. Applies developing subject matter knowledge of GxP regulations and quality systems to resolve routine to moderately complex issues and escalates as appropriate.

Your Contributions (include, but are not limited to):

• Perform day-to-day moderately complex activities for quality systems and processes, including document control, LMS administration, vendor-related processes, investigations, product complaints, change control, CAPA, SCAR, and deviations
• Execute administrative and operational tasks, including data entry, document processing, record maintenance, and reconciliation of QA records to ensure accuracy, completeness, and traceability
• Support the maintenance and use of electronic quality systems, including user support, system documentation, and routine system-related activities
• Review and process controlled documents to ensure proper formatting, completeness, and compliance with company standards and procedures
• Edit, maintain, and process revisions of SOPs, work instructions, and other controlled documents to ensure accuracy and consistency
• Support inspection and audit readiness activities, including coordination and execution of back room and inspection room support
• Generate and maintain routine reports, metrics, trackers, and dashboards to support QA performance monitoring and data integrity
• Collaborate with cross-functional stakeholders to support project deliverables and ensure compliance with GxP requirements and company policies
• Identify and communicate quality or compliance issues within defined processes; escalates and support follow-up actions and resolution
• Support continuous improvement initiatives by identifying opportunities and assisting with implementation within defined scope
• Maintain working knowledge of applicable GxP regulations, internal procedures, and industry standards
• Perform other QA-related duties, as assigned

Requirements:

6+ years of applicable experience/training OR BS/BA degree in Chemistry, Biology, or related field AND 2+ years of relevant experience OR Master’s degree in Chemistry, Biology, or related field AND some similar experience as noted above Strong written and verbal communication skills, with the ability to effectively collaborate with cross-functional stakeholders Solid organizational, planning, and prioritization skills, with the ability to manage multiple tasks in a dynamic environment Strong attention to detail with a focus on accuracy, data integrity, and compliance Demonstrated problem-solving and analytical skills, with the ability to exercise judgment within defined procedures Ability to work effectively both independently and as part of a team Proficiency with standard computer applications and systems Ability to apply company policies and procedures to resolve routine to moderately complex issues Working knowledge of quality systems and compliance processes within a GxP-regulated environment (e.g., deviations, CAPA, change control, document control, training, supplier quality, product complaints) Understanding of applicable regulatory requirements and industry standards (e.g., FDA, ICH, GxP, GMP, GLP, GCP) Experience supporting electronic quality systems (e.g., QMS, LMS) including data entry, record maintenance, and basic system support Knowledge of documentation practices and requirements to ensure accuracy, completeness, and traceability of QA records Familiarity with audit and inspection support activities, including document retrieval and tracking Ability to generate and interpret standard QA reports, metrics, and dashboards to support monitoring and review

Diversity and Inclusion:

Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

Salary and Benefits:

The annual base salary we reasonably expect to pay is $76,800.00-$105,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program.

• retirement savings plan (with company match)
• paid vacation
• holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

Accolades:

We are a top place to work. Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma 2026. We were also named a Great Place to Work Certified company. 2026 2025 Fortune Media IP Limited. All rights reserved. Used under license.

Values:

PASSION: We are driven and love what we do. We are committed to our goals and to making a difference. INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up. COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed. INNOVATION: We seek and create optimal solutions. TENACITY: We do not quit. We adapt. We accomplish what others cannot. Come join our team during this exciting time of growth and opportunities!