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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:
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.
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 escalation 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 support investigations, root cause analysis, and implementation of corrective and preventive actions
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 abi
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Worksite address
san diego, CA, 92189, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.