Neurocrine Biosciences
Executive Director, QA Compliance
US CA San Diego · Director
Sponsorship not specifiedDetected 14 days ago
ComplianceAuditingProcurementGMPFDA RegulatoryPharmacovigilanceMedical DevicesLeadershipCommunicationCollaborationPublic SpeakingInternal AuditGxPRegulatory 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
- Provides strategic leadership and oversight for the Quality Compliance function and is responsible for establishing and maintaining programs that promote sustained regulatory compliance and inspection readiness across Neurocrine's GxP activities.
- Provides leadership for external and internal audit and compliance programs, inspection readiness, management review, quality risk management, GMP laboratory compliance, recall management, and related compliance initiatives.
- Serves as a trusted Quality advisor to senior leadership, providing strategic direction on complex compliance matters, emerging regulatory expectations, quality risks, and opportunities for continuous improvement.
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.
- Own the supplier/vendor quality management system and associated policies (e.g., aligned to ISO 9001, ISO 13485, GxP, or industry-specific standards)
- Establish and maintain vendor quality agreements (VQAs) / quality technical agreements
- Maintain business continuity and contingency plans for high-risk/critical suppliers
- Partner with Procurement on risk-informed vendor selection and contract terms
Requirements
- Bachelor's degree in scientific, engineering, quality, or related applicable field AND 16+ years of applicable experience OR
- Master's degree in applicable field AND 14+ years of applicable experience OR
- PhD or other advanced degree AND 12+ years applicable experience
- Extensive progressive experience in pharmaceutical or biotechnology Quality Assurance and Quality Compliance is required, including significant leadership responsibility for compliance programs and people
- Expert knowledge of applicable GxP regulations, regulatory expectations, and industry standards, including relevant FDA regulations and ICH guidelines
- Demonstrated experience with internal audits across multiple regulated areas, which may include Drug Safety/Pharmacovigilance, Clinical Operations, GMP laboratories, and other auditable systems
- Demonstrated experience with regulatory inspection readiness, inspection management, inspection response, and remediation activities
- Strong knowledge of Quality Management Systems and governance mechanisms used to evaluate and monitor QMS effectiveness
- Extensive knowledge of quality risk management principles and demonstrated ability to establish risk-based approaches to compliance oversight and decision making
Compensation
- Provides strategic oversight of the annual internal audit plan, including risk-based prioritization, governance, execution, escalation of significant findings, and monitoring of corrective and preventive actions
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 )
- Provides strategic leadership and direction for the Quality Compliance function, establishing multi-year strategies, priorities, operating plans, and objectives aligned with broader Quality and company goals
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