QA Operations Manager

## 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](https://c212.net/c/link/?t=0&l=en&o=4450443-1&h=3502828688&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4252873-1%26h%3D4039787179%26u%3Dhttps%253A%252F%252Fwww.neurocrine.com%252F%26a%3Dneurocrine.com&a=neurocrine.com), and follow the company on [LinkedIn](https://c212.net/c/link/?t=0&l=en&o=4450443-1&h=884458364&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4252873-1%26h%3D928986078%26u%3Dhttps%253A%252F%252Fwww.linkedin.com%252Fcompany%252Fneurocrine-biosciences%26a%3DLinkedIn&a=LinkedIn), [X](https://c212.net/c/link/?t=0&l=en&o=4450443-1&h=1730331693&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4252873-1%26h%3D3255611529%26u%3Dhttps%253A%252F%252Ftwitter.com%252Fneurocrine%26a%3DX%2B%28formerly%2BTwitter%29&a=X), [Facebook](https://c212.net/c/link/?t=0&l=en&o=4450443-1&h=3526407131&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4252873-1%26h%3D1536396415%26u%3Dhttps%253A%252F%252Fwww.facebook.com%252FNeurocrine%26a%3DFacebook&a=Facebook) and [YouTube](https://www.youtube.com/@NeurocrineBiosciencesInc). (*\*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), with a particular focus on packaging and labeling and shelf-life extension for clinical trial materials for global studies 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…