Sr. Specialist, QA Operations

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 providing QA support for CGMP drug substance and/or drug product manufacturing. Responsibilities include, with general supervision, reviewing batch documentation, supporting quality events (e.g., deviations, investigations, change management) and interacting with cross functional team members and external manufacturing representatives to ensure product is made in compliance with FDA and EU regulations and other appropriate local regulations and guidance. May participate in conducting internal and/or external audits to ensure compliance with company policies and procedures and applicable guidance and regulations.

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

• Review quality records related to the manufacturing of drug substances and/or drug products of varying modalities (e.g., small molecule, biologics) manufactured by Contract Manufacturing Organizations (CMO) for compliance to CGMPs. Quality records may include executed batch records, deviation investigations, change controls, protocols and reports

• Participate in project teams, serving as the QA representative and escalate issues to senior QA management when appropriate

• Provide Quality support for new product introduction (NPI) processes for new development candidates and/or for substantial changes to existing programs (e.g., new CMO, scale-up, process validation)

• Interface with cross functional team members and CMOs to process quality records and resolve issues

• Manage and/or participate in deviation investigation teams

• Facilitate the change control process for changes related to clinical and/or commercial products

• Participate in or conduct audits of external suppliers

• Participate in compliance inspections and inspection readiness activities as required

• Support and interact with other Quality functional areas to ensure compliance with internal processes and procedures and to promote continuous improvement

• Other duties as assigned

Requirements:<