Sr. Director, Clinical QA

## Sr. Director, Clinical QAApply:
On-Site:
US CA San Diego:
Full time:
Posted Yesterday:
R7336##

Who We Are:

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 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 , and follow the company on Linked In, X, Facebook and You Tube. (
* * in collaboration with Abb Vie*)At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.##

About the Role:

Responsible for developing and leading the strategy and operational plans for Clinical QA and contributing to broader Quality and organizational strategy. Provides strategic leadership for clinical quality and GCP compliance across the clinical development portfolio and establishes the long-term direction, capabilities, processes, and quality systems necessary to support business objectives.
Leads Clinical QA activities and teams responsible for ensuring compliance and effective quality oversight of clinical development activities. Serves as a senior Quality advisor to Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and other key stakeholders, providing strategic guidance on complex and emerging compliance matters. Leads the company through regulatory inspections and provides strategic oversight of clinical audits, inspection readiness, quality risk management, and the clinical Quality Management System (QMS).

Establishes organizational priorities, resource plans, budgets, and performance objectives and develops talent and organizational capabilities to meet current and future business needs. _## Your Contributions (include, but are not limited to):
* Develops and leads multi-year strategy and operational plans for Clinical QA aligned with Quality, R&D, and company objectives. Establishes priorities, capabilities, resources, and measures of success necessary to execute the strategy
* Provides strategic leadership for GCP quality and compliance across the clinical development portfolio and champions a strong Quality Culture throughout the organization
* Serves as a senior Quality advisor and strategic partner to Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and other functional leaders regarding complex compliance issues, emerging risks, and interpretation of global GCP regulatory requirements and expectations
* Leads the development and evolution of the Clinical QA vision, goals, core capabilities, operating model, and long-term roadmap to support evolving business, portfolio, and regulatory needs
* Provides strategic leadership and oversight for regulatory inspection readiness and regulatory inspections, including inspection readiness planning, mock inspections, pre-approval inspections, responses to regulatory authorities, and risk-based management of inspection-related quality events
* Directs the development, implementation, governance, and continuous improvement of the clinical QMS, ensuring systems and processes remain effective, scalable, risk-based, and aligned with evolving global regulatory expectations and business needs
* Establishes and oversees risk-based audit and compliance strategies for global clinical investigators, contract clinical laboratories, CROs, vendors, and other…