Sr. Specialist, QA Systems

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

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.

About the Role:

Responsible for executing and enhancing quality systems and compliance activities within a GxP-regulated environment. Applies advanced knowledge to perform complex activities and ensure quality systems and processes (e.g., deviations, change control, vendor management, product complaints, document control) are executed in compliance with internal procedures and regulatory requirements. Contributes to the continuous improvement of the Quality Management System (QMS) by applying advanced GxP knowledge to enhance processes, systems, and data quality. Collaborates cross-functionally, influences stakeholders within scope, supports process oversight activities, analyzes quality data and trends, and serves as a subject matter resource within the functional area.

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.

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

• Independently perform and coordinate complex activities for quality systems and processes, including document control, LMS administration, vendor management and audits, investigations, product complaints, change control, CAPA, SCAR, and deviations
• Ensure accuracy, completeness, and traceability of QA records through oversight of data entry, document processing, record maintenance, and reconciliation activities
• Support and enhance electronic quality systems, including user support, system documentation, and implementation of system or process improvements within assigned functional scope
• Review and process controlled documents and lead the revision and processing of SOPs, work instructions, and other controlled documents to ensure compliance with established standards
• Support inspection and audit readiness activities, including coordination and execution of back room and inspection room support and follow-up activities
• Generate, analyze, and interpret reports, metrics, trackers, and dashboards to support QA performance monitoring, data integrity, and management review
• Collaborate with cross-functional stakeholders to support project deliverables and ensure compliance with GxP requirements and company policies
• Identify, assess, and elevate quality or compliance issues; support investigations, root cause analysis, and implementation of corrective and preventive actions
• Lead discrete process improvement efforts and contribute to broader continuous improvement initiatives within the functional area
• Provide guidance, coaching, and mentorship to less experienced team members on quality systems, processes, and documentation practices
• Apply sound judgment to resolve complex issues within defined processes and escalade as appropriate
• Perform other QA-related duties, as assigned

Requirements:

Bachelor’s degree from an accredited college or university with emphasis in a relevant field AND 4+ years of relevant experience within the pharmaceutical/biotech industry managing various quality assurance related activities (e.g. training, change control, investigations, systems OR Master’s Degree AND 2+ years of relevant work experience as noted above Strong verbal and written communication skills, with the ability to effectively engage and influence cross-functional stakeholders within scope Strong organizational, planning, and prioritization skills, with the ability to manage multiple competing priorities with a high degree of accuracy Advanced proficiency with standard computer applications and systems Ability to analyze information, apply critical thinking, and exercise sound judgment to resolve complex issues within defined parameters Ability to work independently with minimal supervision and collaboratively across teams Demonstrated problem-solving and analytical skills, including the ability to evaluate data and identify trends Ability to provide guidance and support to less experienced team members Strong attention to detail with the ability to balance accuracy with efficiency Strong knowledge of quality systems and compliance processes within a GxP-regulated environment (e.g., deviations, CAPA, change control, document control, supplier quality, product complaints) Strong understanding of regulatory requirements and industry standards (e.g., FDA, ICH, GxP, GMP, GLP, GCP) Experience with electronic quality systems (e.g., QMS, LMS), including system administration, support, and process improvement Knowledge of documentation practices, data integrity principles, and requirements for audit and inspection readiness Experience supporting audits and inspections, including preparation, coordination, and response support Demonstrated ability to identify process improvement opportunities and implement enhancements within functional area Demonstrated leadership skills, including leading smaller initiatives and providing mentorship or guidance to junior staff Ability to analyze quality data, metrics, and trends to support decision-making and continuous improvement Openness to feedback and ability to incorporate guidance

How We Compensate:

The annual base salary we reasonably expect to pay is $97,000.00-$133,000.00. 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.

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

OUR 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.

Our Recognition:

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

Why Join Us:

Come join our team during this exciting time of growth and opportunities! (#LI-RS1)