Senior Director, Global GMP/GDP Audit and Predictive Compliance Intelligence

BioSpace; Washington (District of Columbia); Presencial; USD 260.000 - 420.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Retirement and Savings Plan

Medical/dental/vision coverage

Stock-based incentives

Flexible time-off programs

Flexible work models

Descripción de la vacante

Amgen seeks a Senior Director to lead the global GMP/GDP audit and predictive compliance intelligence capability. You will shape the strategy, oversee internal audits of manufacturing sites, suppliers, laboratories, and contract organizations while guiding AI-enabled risk insights to prioritize remediation and improvement.

The role partners with RRIR, ILM, External Affairs, and senior leadership to deliver inspection readiness, proactive risk mitigation, and continuous improvement in quality and

Formación

• Advanced degree in a life sciences or related field with regulatory expertise.
• Evidence of leading large-scale audit and risk-management programs.
• Experience in applying analytics/AI to compliance and risk management.

Responsabilidades

• Lead the global GMP/GDP audit organization and predictive compliance intelligence capability.
• Establish strategic direction, operating model, and multiyear roadmap for both capabilities.
• Oversee global risk-based GMP/GDP audit strategy and master audit schedule.
• Ensure audit program depth across manufacturing, labs, suppliers, and distribution.
• Develop predictive models, dashboards, and early warning indicators for audit priorities.

Conocimientos

Biologics manufacturing

Regulatory compliance

Auditing

Leadership

Analytics

Educación

Doctorate degree

Master's degree

Bachelor's degree

Descripción del empleo

Join Amgens Mission of Serving Patients

Senior Director, Global GMP/GDP Audit and Predictive Compliance Intelligence

What you will do

Lets do this. Lets change the world. The Senior Director is the single accountable leader for Amgens global GMP/GDP audit organization and predictive compliance intelligence capability.

The role leads an integrated enterprise function combining independent audit assurance, deep Operations compliance expertise, advanced analytics, AI-enabled tools, regulatory intelligence, inspection outcomes, supplier performance, and internal quality signals.

The Senior Director is accountable for the technical depth, strategic direction, execution, and effectiveness of the global audit program while building a forward-looking capability that identifies emerging compliance risks and enables earlier enterprise intervention.

The Role Leads Two Fully Integrated Capabilities

Global GMP/GDP Audit, including internal audits of manufacturing sites, programs, and quality systems, and audits of suppliers, contract manufacturers, laboratories, distributors, and other regulated service providers.

Predictive Compliance Intelligence, focused on identifying weak signals, forecasting compliance vulnerabilities, detecting systemic trends, and translating intelligence into audit priorities and broader risk-mitigation actions.

The function is intended to move the organization beyond retrospective identification of deficiencies toward earlier detection, prioritization, and prevention of significant regulatory and quality risks.

Key Responsibilities

• Serve as the single accountable leader for the global GMP/GDP audit organization and predictive compliance intelligence capability.
• Establish the strategic direction, operating model, technical standards, and multiyear roadmap for both capabilities.
• Lead the global risk-based GMP/GDP audit strategy and master audit schedule.
• Ensure the audit program maintains sufficient technical depth to evaluate manufacturing operations, laboratories, quality systems, suppliers, contract manufacturers, and distribution activities.
• Oversee audit planning, scope, execution, finding classification, reporting, CAPA assessment, effectiveness verification, escalation, and closure.
• Establish expectations for process-based, inspection-ready auditing that evaluates actual execution, system effectiveness, product impact, data integrity, and broader applicability.
• Determine when emerging risks require expanded audit scope, targeted assessments, for-cause audits, multi-site evaluation, or executive escalation.
• Build the predictive compliance intelligence capability, including its data strategy, analytical methods, technology roadmap, governance interfaces, talent model, and performance measures.
• Integrate audit data, inspection outcomes, regulatory trends, supplier performance, deviations, CAPAs, complaints, recalls, and other quality signals into a consolidated enterprise risk view.
• Develop predictive models, dashboards, early-warning indicators, and risk scenarios to guide audit priorities and proactive intervention.
• Identify systemic risks and recurring failure mechanisms across sites, suppliers, products, processes, and quality systems.
• Lead the technical capability strategy for auditors, including competency requirements, qualification standards, continuing education, and access to appropriate subject-matter expertise.
• Oversee AI-enabled audit and compliance intelligence tools.
• Ensure AI supports, but does not replace, qualified human judgment, accountable Quality decisions, audit independence, and objective evidence.
• Serve as a GMP/GDP advisor to the separate enterprise AI governance organization.
• Provide senior leadership with clear, actionable insight on emerging compliance risks and recommended interventions.
• Lead and develop a highly qualified, multidisciplinary global audit and compliance intelligence organization.
• Own the audit continuous-improvement roadmap and measures of audit effectiveness, not merely audit completion.

Regulatory Compliance Collaboration

The Role Will Partner Closely With:

• Regulatory Reporting and Inspection Readiness (RRIR) to apply audit and predictive intelligence to inspection readiness forums, pressure testing, mock inspections, inspection strategy, on-site inspection support, and response development for significant or multisite findings.
• Inspection Lifecycle Management (ILM) to integrate audit findings with inspection outcomes and lessons learned. ILM retains ownership of observation ratings, inspection scoring, and regulatory commitment tracking and closure.
• External Affairs to monitor emerging health-authority policy, enforcement priorities, and regulatory trends and translate them into audit, surveillance, and compliance priorities.

Measures of Success

The global audit program demonstrates increased technical depth, challenge, consistency, and inspection relevance.

Predictive compliance intelligence is established as a credible and actionable enterprise capability.

The function identifies meaningful risks that would not have been detected through the routine audit program alone.

Significant risks are identified before they result in major inspection, product, supply, or compliance events.

Audit, inspection, commitment, supplier, quality, and external regulatory intelligence are integrated into a common enterprise risk view.

Audit scope and priorities respond dynamically to predictive signals, inspection outcomes, supplier performance, and external regulatory trends.

Audit intelligence strengthens RRIR inspection readiness and response strategy.

ILM receives timely audit information to support inspection scoring, lessons learned, and commitment oversight.

Recurring findings decrease, systemic issues are identified early, and corrective actions are sustainable.

Auditor technical capability improves against defined competency standards.

AI-enabled tools improve risk detection and audit effectiveness while maintaining human accountability and audit independence.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic leader we seek is an individual with these qualifications

Basic Qualifications

• Doctorate degree and 5 years of biologics manufacturing and regulatory compliance experience OR
• Masters degree and 9 years of biologics manufacturing and regulatory compliance experience OR
• Bachelors degree and 11 years of biologics manufacturing and regulatory compliance experience
• AND
• In addition to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications

• Significant leadership experience in pharmaceutical or biotechnology Quality, auditing, compliance, manufacturing, regulatory affairs, analytics, or related disciplines.
• Demonstrated depth in Operations GMP/GDP compliance and the ability to independently evaluate complex manufacturing, laboratory, quality-system, supplier, and distribution risks.
• Experience leading a global audit, supplier-quality, inspection-readiness, quality-system, or compliance-intelligence organization.
• Demonstrated experience building or substantially transforming an enterprise capability, program, or operating model.
• Experience applying analytics, AI, or digital tools to compliance and risk management.
• Strong knowledge of global health-authority inspection expectations and enforcement trends.
• Demonstrated ability to identify emerging risk, make difficult compliance judgments, and influence enterprise decisions.
• Demonstrated ability to lead multidisciplinary teams and senior cross-functional stakeholders.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

Equal Opportunity

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.