Sr. Clinical Quality Assurance Manager - San Diego/Hybrid

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:

As the Sr. Clinical Quality Assurance Manager at Neurocrine, you will be a pivotal leader in ensuring the highest quality standards are upheld across our diverse clinical research portfolio. Leveraging your deep expertise in Quality Assurance, you will spearhead CQA activities that support the development and commercialization of transformative therapies, primarily in neurology with support for psychiatry therapeutic areas.

Your QA leadership and training will be instrumental in driving adherence to all relevant regulatory requirements and internal policies and procedures. You will partner closely with cross-functional teams to implement robust quality systems and processes that mitigate risks and position our clinical programs for success.

This is an exceptional opportunity to make a tangible impact on Neurocrine's mission of developing life-changing medicines. If you are a seasoned quality professional, local to San Diego and have a passion for excellence, we encourage you to apply.

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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

• 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, pro