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 patients with 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 providing Quality oversight and technical support for GMP manufacturing activities performed by Contract Manufacturing Organizations (CMOs). Independently executes and supports core quality processes including batch record review, deviation investigations, change control assessment, and support for new product introductions. Operates through technical expertise, collaboration, and sound quality decision-making to ensure compliance with cGMP regulations, internal quality systems, and regulatory expectations. May lead projects or initiatives through cross-functional influence but does not have direct people management responsibility._
Your Contributions (include, but are not limited to):
Quality Operations & Technical Execution
Independently review and approve quality records associated with GMP products manufactured by CMOs, ensuring compliance with cGMP regulations, internal procedures, and quality standards
Support timely and compliant batch disposition activities through review of batch documentation, investigation outcomes, and supporting quality data
Assess and escalate quality risks, compliance concerns, and potential product impact issues to senior QA leadership as appropriate
Execute quality oversight activities supporting GMP manufacturing operations and associated quality systems
Cross-Functional Collaboration
Serve as the Quality representative on assigned cross-functional teams and initiatives, providing Quality guidance and supporting issue resolution activities
Support Quality activities related to new product introductions (NPI), process validation, scale-up activities, technology transfers, and lifecycle management initiatives
Collaborate with internal stakeholders and external partners, including CMOs and suppliers, to facilitate resolution of quality issues and maintain alignment with quality expectations
Investigations, Change Control & Compliance
Conduct deviation investigations and support root cause analysis activities using established investigation methodologies and risk-based approaches
Provide Quality input into change control activities, supporting evaluation of quality impact and compliance with internal procedures and regulatory expectations
Participate in internal and external audits and support inspection readiness activities
Support regulatory inspections by providing documentation, responding to requests, and communicating quality processes as needed
Continuous Improvement & Expertise
Support continuous improvement initiatives that strengthen quality systems, improve operational effectiveness, and maintain compliance
Apply technical knowledge and experience to identify process improvement opportunities and recommend solutions within area of responsibility
Maintain current knowledge of applicable regulatory requirements, GMP expectations, and industry practices
Mentor less experienced colleagues and share technical knowledge within the Quality organization
Perform additional responsibilities as required to support Quality operations and organizational priorities
Requirements:
BS/BA degree in Chemistry, Biology, or related field AND 6+ years of relevant experience with a minimum of 4 years of Quality experience within the pharmaceutical or biotechnology industry OR
Master’s degree in life sciences or related field AND 4+ years of similar experience noted above
Ability to work effectively in a team environment and collaborate across functions.
Strong organizational and time management skills with the ability to manage multiple priorities
Detail-oriented with solid analytical and problem-solving capabilities
Effective written and verbal communication skills
Ability to follow established processes and apply sound judgment within defined procedures
Ability to assess information, identify issues, and communicate requirements clearly to appropriate stakeholders
Knowledge of FDA and EU regulations and ICH guidelines applicable to cGMP drug substance and drug product manufacturing
Hands-on experience reviewing GMP quality records (e.g., batch records, deviations, change controls, CAPAs, specifications)
Experience supporting batch disposition activities and quality decision-making processes
Working knowledge of deviation investigation methodologies (e.g., 5 Whys, fishbone analysis)
Familiarity with electronic quality management systems (eQMS)
Ability to identify, assess, and escalate quality risks appropriately
#LI-SA1
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 $119,700.00-$164,000.00. 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 30% 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.