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

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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

What you will do

Let’s do this. Let’s change the world. The Senior Director is the single accountable leader for Amgen’s 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 earlier, 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
• Master’s degree and 9 years of biologics manufacturing and regulatory compliance experience OR
• Bachelor’s 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, we’ll 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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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.

Apply now and make a lasting impact with the Amgen team.

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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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.