Neurocrine Biosciences
Sr. Director, Clinical QA
US CA San Diego · Director
Sponsorship not specifiedDetected 8 days ago
GCPComplianceProduct ManagementAuditingPerformance ManagementClinical TrialsClinical ResearchGMPFDA RegulatoryPharmacovigilanceMedical DevicesResearchLeadershipCommunicationCollaborationMentoringInternal AuditBiostatisticsRegulatory Affairs
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odds of building a lasting career here
40Risky
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- 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.
- Your Contributions (include, but are not limited to):
- Establishes priorities, capabilities, resources, and measures of success necessary to execute the strategy
Responsibilities
- 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.
- 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.
- Establishes meaningful quality metrics, trends, and risk indicators for Clinical QA and communicates insights, emerging risks, and recommendations to senior leadership to support informed decision-making
Requirements
- Extensive GCP audit, inspection, clinical quality systems, and regulatory compliance experience required.
- Significant people leadership experience required.
- Master's degree in a similar field as noted above AND 12+ years of applicable experience as noted above.
- PhD in a similar field as noted above AND 10+ years of applicable experience as noted above
- Recognized as an internal thought leader with deep technical and business expertise and the ability to become a company-wide advisor and emerging external industry expert
- Strong strategic mindset with the ability to anticipate emerging business, regulatory, and industry trends and incorporate them into long-term plans and organizational priorities
- Strong decision quality and judgment, including the ability to assess complex risks, integrate diverse perspectives, and make timely decisions with long-term organizational implications
- Ability to serve as a trusted advisor and advocate for Quality while balancing compliance, patient safety, business objectives, and organizational priorities
- Expert knowledge of clinical trial-related FDA regulations, ICH Guidelines, and international GCP regulations and guidelines
- Expert knowledge of auditing principles, techniques, inspection readiness, regulatory inspection management, quality risk management, and corrective and preventive action processes
Benefits
- 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
Company info
- 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 neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. ( *in collaboration with AbbVie )
- 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.
- 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 neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. ( *in collaboration with AbbVie )
- 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).
- 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
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This listing is sourced directly from Neurocrine Biosciences's careers page and normalized into a canonical job model.