Sr. Manager, QA Systems

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:

Provides oversight for the development, implementation and maintenance of document control program, systems, and procedures, ensuring adherence to policies and established industry standards. Offers experienced guidance in interpreting policies, regulations, and governmental guidelines to guarantee compliance. Manages day-to-day document control activities and engages with document owners and GXP leaders on controlled documents. Works closely with operational units to continuously analyze processes, enforce requirements, and meet standards. Assists with audit and inspection activities. Provides support for both developmental and commercial products for Neurocrine locations within and outside of the United States. Ensures QA oversight to comply with company policies, ICH, FDA, EU requirements, cGMP, and other applicable standards.

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

• Lead and manage the document control team

• Provide guidance and input related to the creation of new controlled document types and eDMS enhancements

• Develop, implement, and maintain the Quality Management System (QMS) and associated procedures (SOPs) related to document control, records retention, and training, ensuring regulatory compliance

• Implement and manage the electronic Document Management Systems (eDMS)

• Train QADC personnel and eDMS users on document control processes, procedures and applicable regulations and guidelines

• Oversee the document lifecycle, including creation, review, approval, distribution, archival, and destruction of controlled documents

• Manage the document control room and serve as the point of contact for offsite QA Document Control storage

• Serve as a subject matter expert during audits and inspections by regulatory agencies and clients, facilitating document retrieval and presentation

• Identify opportunities for process improvements and drive continuous improvement initiatives related to document control

• Establish operational objectives, work pla