Neurocrine
QA Operations Manager
US CA San Diego
Sponsorship not specified$120k-$164kDetected 12 days ago
Process ImprovementCustomer SupportGMPFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingTime Management
About the role
- Operates through technical expertise, collaboration, and sound quality decision-making to ensure compliance with cGMP regulations, internal quality systems, and regulatory expectations.
- Your Contributions (include, but are not limited to):
- Quality Operations & Technical Execution
Responsibilities
- 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.
- Support timely and compliant batch disposition activities through review of batch documentation, investigation outcomes, and supporting quality data
- 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
- Conduct deviation investigations and support root cause analysis activities using established investigation methodologies and risk-based approaches
- 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
- Support continuous improvement initiatives that strengthen quality systems, improve operational effectiveness, and maintain compliance
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 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
- 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
Compensation
- The annual base salary we reasonably expect to pay is $119,700.00-$164,000.00.
Company info
- 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. _
- 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 )
- to relieve suffering for people with great needs.
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