Assoc. Director, QC

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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 and Facebook. (*in collaboration with AbbVie)

About the Role:

Responsible for leading QC operations, ensuring the timely and compliant release of raw materials, in-process samples, drug substance, and drug product performed by contract sites and internal GMP analytical laboratory operations. This role provides scientific leadership, oversees method lifecycle management, and ensures QC systems meet all applicable regulatory requirements (FDA, EMA, ICH, USP). Partners cross-functionally with Quality Assurance, Manufacturing, Regulatory Affairs, and CMC teams to support clinical and commercial programs.

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

• Review and approve API and drug product analytical records for clinical and commercial products
• Review and approve stability data supporting retest period assignment for clinical and commercial products
• Review and approve internal and external test method validation protocols and reports
• Review and approve equipment/instrument qualification, calibration and maintenance records to support the internal GMP lab
• Participate in project teams, serving as the QC representative and escalate issues to senior Quality management when appropriate
• Interact with cross-functional team members, external manufacturing sites and contract testing labs to resolve analytical testing issues
• Lead or participate in deviation and laboratory investigation teams
• Facilitate the change control process for analytical changes related to clinical and commercial products
• Prepare reports for management review of key statistics such as vendor performance based on findings from analytical record reviews
• Author and review controlled documents, including Standard Operating Procedures, analytical methods, protocols and reports related to lab activities
• Author and review analytical modules in regulatory submissions
• Conduct and support audits of external vendors
• Assist during onsite inspections and inspection readiness activities
• May lead junior staff and/or cross-functional teams
• Perform additional duties as assigned by management

Requirements: