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

Location: United States — Remote

Annual salary: USD 198,330.50–268,329.50

Company

Biotechnology company developing and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead the global GMP/GDP audit organization and predictive compliance intelligence capability.
• Set the strategic direction, operating model, technical standards, roadmap, and performance measures for both capabilities.
• Direct risk-based audits across manufacturing sites, laboratories, quality systems, suppliers, contract manufacturers, distributors, and other regulated providers.
• Integrate audit findings, inspection outcomes, supplier performance, deviations, CAPAs, complaints, recalls, and regulatory trends into an enterprise risk view.
• Develop predictive models, dashboards, early-warning indicators, and risk scenarios to support proactive intervention.
• Build and develop a multidisciplinary global organization while overseeing AI-enabled tools and maintaining audit independence and human judgment.

Requirements

• Doctorate degree plus 5 years of biologics manufacturing and regulatory compliance experience, or a master’s degree plus 9 years, or a bachelor’s degree plus 11 years.
• At least 5 years of direct people management or leadership experience involving teams, projects, programs, or resource allocation.
• Significant leadership experience in pharmaceutical or biotechnology Quality, auditing, compliance, manufacturing, regulatory affairs, analytics, or a related discipline.
• Strong GMP/GDP compliance expertise and the ability to assess complex manufacturing, laboratory, quality-system, supplier, and distribution risks.
• Knowledge of global health-authority inspection expectations and enforcement trends.
• Ability to identify emerging risks, make complex compliance judgments, and influence senior cross-functional stakeholders.

Nice to have

• Experience leading a global audit, supplier-quality, inspection-readiness, quality-system, or compliance-intelligence organization.
• Experience building or transforming an enterprise capability, program, or operating model.
• Experience applying analytics, AI, or digital tools to compliance and risk management.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus opportunity and stock-based long-term incentives.
• Paid time off and career development opportunities.
• Flexible work models where applicable.

Hiring process

• Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
• Sponsorship is not guaranteed.