Sr. Manager, QA Systems presso Neurocrine Biosciences

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 plans and KPIs for document control activities

• Track and report quality performance metrics to senior leadership

• Stay up to date with industry trends, regulations, and best practices in quality management

• Support the development of all controlled documents and related training curriculums

• Partner with QA management to drive strategies to ensure compliance with regulations, guidelines and company SOPs across the organization, and lead QA initiatives as assigned

• Apply risk-based decision-making and integrate into department systems and processes, as appropriate

• Proactively identify areas for improvement and collaborate with QA and GXP departments on continuous improvement initiatives

• Aligns department projects and goals with company objectives and principles

• May work on other projects within QA not related to GXP

• Other duties as assigned

Requirements:

• BS/BA degree in Chemistry, Biology, RN, or related field and 8+ years of scientific or health care field and pharmaceutical industry experience, including 5+ years of CQA experience in drug development OR

• Masters degree in Chemistry, Biology, or related field and 6+ years of similar experience noted above

• Previous managerial / functional management experience also required

• Proven track record and experience in searching, review and implementation of regulatory requirements and guidelines including research of principal investigator regulatory histories

• In-depth knowledge of Quality Management Systems (QMS), document control principles, data integrity, and good documentation practices (GDP)

• Experience in implementing and managing electronic Document Management Systems (eDMS)

• Ability to identify and escalate problems and follow-through with the corrective actions

• Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors

• Proven ability to quickly learn new information and communicate requirements to the appropriate individuals

• Excellent verbal and written communication skills along with sound organization skills applicable to audit planning, reporting and archiving

• Ability to adapt to changing circumstances and manage multiple work streams

• Requires broad understanding of the processes, procedures and systems used to accomplish the team’s work and familiarity with the underlying concepts in other disciplines within the function

• Applies in-depth understanding of how own discipline integrates within the function and understands contribution to Neurocrine's achievement of business objectives

• Ability to work as part of and lead multiple teams

• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams

• Excellent computer skills

• Excellent problem-solving and analytical thinking skills

• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

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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.

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The annual base salary we reasonably expect to pay is $140,800.00-$204,000.00. 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 30% 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. Candidarsi ora