New

Sr. Specialist, QA Operations

Neurocrine Biosciences
United States, California, San Diego
Jul 21, 2025
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 Biosciencesis 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (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. _ 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: B.S. Degree in Chemistry, Biology, or related field and 4+ years of experience in quality within the pharmaceutical or biotechnology industry OR Master's degree and 2+ years of experience in quality within the pharmaceutical or biotechnology industry Basic knowledge of FDA and EU regulations and ICH Guidelines and their applicability to CGMP drug substance and drug product manufacturing Hands-on experience reviewing quality records related to pharmaceutical manufacturing such as batch records, labeling, deviation reports, analytical test reports, specifications, change controls, CAPAs Ability to identify and escalate problems and follow-through with corrective actions Experience with investigation methodologies (e.g., fishbone diagrams, 5 Whys, pareto charts) Ability to work closely with both internal and external personnel Experience with electronic quality management systems Works well in a team environment Strong organizational and time management skills Ability to meet multiple deadlines with a high degree of accuracy and efficiency Attention to detail, critical thinker and effective organizational skills Strong verbal and written communication skills Ability to quickly learn new information and communicate requirements to the appropriate individuals #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. _ The annual base salary we reasonably expect to pay is $95,100.00-$138,050.00. 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.