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San Diego, California, United States
Onsite
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)
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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 escalate 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 escalate as appropriate
Perform other QA-related duties, as assigned
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
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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.
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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.