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

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), Inspection Lifecycle Management (ILM), and External Affairs to integrate audit and predictive intelligence into inspection readiness, response development, and regulatory trend monitoring.

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.

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
• At least 5 years' experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

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.