Sr. Clinical Quality Assurance Manager

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, but few options.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. 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, 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 (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

Responsible for driving and leading Clinical Quality Assurance (CQA) activities in support of research projects across multiple therapeutic areas for development and commercial products. Provides Quality Assurance (QA) expertise, leadership, and training to ensure adherence with applicable regulatory requirements and company policies/procedures.

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

• Primary - Study Team Support:

  • Serve as the CQA Lead for complex programs, including those requiring unblinded CQA roles

  • Develop risk mitigation plans and strategies

  • Monitor the regulatory status of clinical investigators as well as study/site/vendor issues for GCP risks and take action when necessary

  • Provide guidance on remediation and corrective action plans to ensure all parts of the study are conducted properly and in compliance

  • Lead site inspection preparation activities and review inspection findings and responses in conjunction with QA management

  • Provide GCP training as needed, including Investigator Meeting training

• Secondary - Good Clinical Practice (“GCP”) Audit Management:

  • Lead, plan, conduct, and oversee GCP audits (e.g., vendor, clinical investigator site, internal audits) to ensure compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans, and applicable policies/procedures

  • Develop and lead the execution of audit plans for assigned programs in line with overall QA annual audit plans, including audit resourcing, oversight of consultant auditors, and communications to internal and external stakeholders as applicable.

  • Assist in the audit site selection process for study-specific audit plans

  • Ensure timely audit conduct, reporting, review, and closeout in accordance with Company SOPs

  • Maintain current and accurate audit records, including CQA audit schedules, files, and audit database/tracker

  • Provide proactive audit status and metrics reports to management

• Quality Systems:

  • Work with (may lead) a multidisciplinary team to standardize clinical development activities within and across programs through preparation of SOPs and personnel training

  • Proactively research, test and implement quality systems, processes and procedures within CQA area

  • Develop and assess GCP metrics, conduct trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities) for management reporting. Proactively identify areas for improvement and collaborate with QA and GCP departments on continuous improvement initiatives

• QA Department Support:

  • Partner with QA management to drive strategies to ensure compliance to regulations, guidelines and company SOPs across