From Neurocrine's posting. “We” and “our” refer to the employer.
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. _
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
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.
_
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.
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LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
