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 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.
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. Partners across Quality and with cross-functional stakeholders to ensure compliance programs are risk-based, effective, scalable, and aligned with Neurocrine's business and development objectives.
Leads and develops the Quality Compliance organization, establishes strategic priorities and operating plans, and promotes a strong culture of quality, accountability, continuous improvement, and inspection readiness across the organization.
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Your Contributions (include, but are not limited to):
- 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
- Leads external audit program and establishes a risk-based audit strategy encompassing GxP vendors and service providers
- Own the supplier/vendor quality management system and associated policies (e.g., aligned to ISO 9001, ISO 13485, GxP, or industry-specific standards)
- Define quality requirements, acceptance criteria, and KPIs for vendor onboarding and ongoing performance
- Establish and maintain vendor quality agreements (VQAs) / quality technical agreements
- Lead supplier qualification, requalification, and risk-based audit programs
- Segment and score vendors by quality/compliance risk criticality
- Maintain business continuity and contingency plans for high-risk/critical suppliers
- Partner with Procurement on risk-informed vendor selection and contract terms
- Conduct or oversee on-site and remote audits (quality systems, manufacturing processes, documentation practices)
- Approve, conditionally approve, or disqualify vendors based on audit findings and risk assessments
- Leads the internal audit program and establishes a risk-based audit strategy encompassing applicable GxP systems and functions, including Drug Safety/Pharmacovigilance, Clinical Operations, GMP laboratories, and other auditable systems
- 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
- Establishes and maintains an organizational inspection readiness program to ensure ongoing preparedness for regulatory inspections and other external assessments
- Maintain audit-ready documentation and evidence for internal/external inspections
- Monitor regulatory changes and update vendor compliance requirements accordingly
- Manage vendor-related regulatory findings, warning letters, or non-conformance
- Provides leadership and strategic direction during regulatory inspections, including inspection preparation, coordination, response strategy, remediation, and management of inspection commitments, as applicable
- Leads Quality Management Review activities, ensuring senior leadership has appropriate visibility to quality performance, compliance trends, emerging risks, significant quality issues, and effectiveness of compliance programs
- Provides strategic oversight for GMP laboratory compliance and partners with applicable Quality, Technical Operations, and laboratory stakeholders to identify, assess, and mitigate compliance risks
- Leads and continuously improves the Quality risk management framework, including development and oversight of risk assessments and processes for identifying, evaluating, escalating, mitigating, and monitoring significant quality and compliance risks
- Provides strategic oversight of recall management processes and ensures appropriate governance, cross-functional coordination, escalation, and execution of product recall activities, as applicable
- Drives continuous improvement of SOPs, compliance processes, tools, and governance mechanisms based on regulatory expectations, inspection and audit trends, business needs, and identified risks
- Establishes meaningful compliance metrics, dashboards, and key performance indicators to monitor organizational compliance, identify trends, and inform risk-based decision making and management review
- Provides governance and strategic oversight for Quality Compliance data and systems, including applicable Veeva organizations, risk classifications, supplier categories, audit certifications, questionnaires, and related compliance information
- Ensures risk classifications, compliance questionnaires, and other compliance assessment tools are periodically reviewed and updated to reflect evolving regulatory requirements and business needs
- Serves as a senior Quality Compliance advisor to Quality leadership and cross-functional stakeholders on complex or high-risk compliance matters
- Interprets emerging regulatory requirements and industry trends and assesses their potential impact to Neurocrine's Quality operations and compliance strategy
- Partners across Quality and with Clinical Operations, Drug Safety/Pharmacovigilance, Technical Operations, Regulatory Affairs, R&D, and other functions to drive integrated and sustainable compliance solutions
- Promotes organizational awareness of quality and compliance expectations through effective communication, education, and compliance-related communications and initiatives
- Develops, leads, mentors, and retains a high-performing Quality Compliance organization; establishes clear expectations and accountability while building organizational capability and succession readiness
- Provides leadership through subordinate leaders and/or high-level professionals and effectively manages resources, priorities, and organizational capabilities required to achieve Quality Compliance objectives
- Champions a culture of quality, integrity, accountability, risk-based decision making, continuous improvement, and proactive compliance throughout Neurocrine
- Performs other duties as assigned
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
- Prior experience leading a Quality Compliance function or major compliance organization, including responsibility for external and internal audits, regulatory inspection readiness, Management Review, quality risk management, GMP compliance, and senior-level compliance governance, is strongly preferred
- Extensive Quality Assurance and Quality Compliance experience within the pharmaceutical, biotechnology, or other highly regulated life sciences industry
- Expert knowledge of applicable GxP regulations, regulatory expectations, and industry standards, including relevant FDA regulations and ICH guidelines
- Extensive experience developing, leading, and continuously improving risk-based external audit and compliance programs across multiple GxP disciplines
- 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 developing, reviewing, and approving audit plans and establishing risk-based approaches to audit planning and execution
- 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
- Demonstrated experience leading or supporting Management Review and presenting quality metrics, trends, risks, compliance issues, and recommendations to senior leadership
- Extensive knowledge of quality risk management principles and demonstrated ability to establish risk-based approaches to compliance oversight and decision making
- Demonstrated experience developing, conducting, reviewing, and maintaining Quality and compliance risk assessments
- Strong understanding of GMP laboratory compliance and applicable regulatory expectations for pharmaceutical laboratory operations
- Knowledge of recall management requirements and demonstrated experience supporting or overseeing recall preparedness, governance, coordination, and execution
- Demonstrated ability to identify opportunities for SOP improvement and lead development, revision, and implementation of procedures to address regulatory, operational, or compliance needs
- Experience developing, reviewing, and updating compliance questionnaires and related assessment tools
- Experience with electronic Quality Management Systems and compliance technology platforms; experience with Veeva Quality applications strongly preferred
- Experience managing or overseeing Quality information within Veeva Organizations, including risk classifications, supplier categories, audit certifications, and related compliance records
- Demonstrated ability to identify systemic compliance risks and drive cross-functional corrective, preventive, and continuous improvement initiatives
- Experience developing and monitoring compliance metrics, key performance indicators, dashboards, and other mechanisms used to identify trends and support senior management decision making
- Demonstrated ability to interpret new and evolving regulatory requirements, assess organizational impact, and develop appropriate compliance strategies
- Experience establishing governance frameworks, policies, procedures, and standards that promote sustained inspection readiness and regulatory compliance
- Strong knowledge of pharmaceutical development and commercialization environments and the interdependencies among Quality, Clinical Operations, Drug Safety/Pharmacovigilance, Regulatory Affairs, Technical Operations, laboratories, R&D, and other GxP functions
- Demonstrated success interacting with senior leadership, regulatory authorities, vendors, and other external stakeholders on significant quality and compliance matters
- Proven people leadership experience, including experience leading through other managers, leaders, and/or senior-level professionals
- Demonstrated ability to effectively manage resources, priorities, organizational capabilities, and functional operating plans within a complex Quality organization
- Consistently acts as a trusted advisor across the organization and provides strategy, vision, and direction on matters that may have company-wide impact
- Deep expertise within Quality Assurance and Quality Compliance, combined with broad understanding of pharmaceutical development, manufacturing, regulatory requirements, and related GxP functions
- Demonstrated ability to develop and execute long-term functional strategies and translate complex organizational objectives into actionable operating plans
- Demonstrated ability to anticipate factors that could impact company strategy, regulatory compliance, operational effectiveness, or Neurocrine's position within the industry
- Proven ability to evaluate complex and ambiguous issues, assess multiple variables and risks, and develop innovative, practical, and sustainable solutions
- Strong business acumen and ability to balance regulatory requirements, patient protection, quality risk, operational priorities, and business objectives in complex decision making
- Demonstrated ability to influence senior management and executive leadership and align stakeholders across organizational and functional boundaries
- Exceptional written and verbal communication skills, including the ability to communicate complex compliance matters clearly and effectively to executive leadership, regulatory authorities, and diverse internal and external audiences
- Proven leadership skills with demonstrated ability to build, develop, mentor, motivate, and retain high-performing teams and leaders
- Demonstrated ability to lead through organizational change and establish accountability for execution, ethical standards, compliance, and results
- Strong strategic thinking, decision quality, problem-solving, analytical, and risk-management capabilities
- Demonstrated ability to establish organizational priorities, frameworks, policies, and processes that support long-term functional success
- Demonstrated ability to build impactful cross-functional teams and foster collaboration, engagement, accountability, continuous learning, and high performance
- Ability to operate effectively in a complex, evolving, and highly regulated environment while maintaining a long-term strategic and enterprise perspective
- Demonstrated ability to develop organizational capability and talent, including mentoring leaders, succession planning, and building a strong leadership bench
- Ability to assess functional performance, establish meaningful success measures, and drive results through managers, senior professionals, and cross-functional partners
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Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
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The annual base salary we reasonably expect to pay is $227,000.00-$398,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.