Director, Quality Risk Management

This leader provides strategic direction and oversight to ensure that QRM principles, risk-based thinking and proactive quality approaches are deeply embedded across the Pharmaceutical Quality System (PQS) and operations. The role is accountable for designing, implementing, and sustaining compliant, scalable, and efficient global processes that enable early risk identification, effective risk mitigation, and continuous improvement aligned with cGMP, ICH, and evolving global regulatory expectations.

Key Accountabilities

Global Business Process Responsibilities and Governance

• Define and execute the global Quality Risk Management framework, with enterprise accountability for strategy, standards, performance, and continuous improvement
• Design, own, and approve global standards, policies, procedures and training ensuring alignment with cGMP, ICH, and applicable regulatory expectations
• Drive the evolution of organizational risk maturity, capability, and culture, embedding proactive approach to risk and risk-based thinking
• Drive, implement and monitor QRM Master Plans and living Risk Assessment Portfolios across PDM
• Ensure effective integration and alignment of Risk and Change Management processes across the PQS
• Ensure effective integration of Proactive HOP process and human-centric risk mitigation approaches
• Collaborate with the Medical Device and Combination Product (MDCP) team to harmonize QRM and MDCP risk management frameworks
• Oversee the enterprise Quality Risk Register and development of the Operations Quality risk profile
• Serve as the Module Business Process Lead for the electronic QRM system (e.g., GVault Risk Module)
• Ensure strong cross-functional collaboration with Technical, Regulatory, Safety, and Operations partners
• Lead and actively contribute to QRM-related projects and initiatives
• Define, implement and monitor metrics, KPIs and dashboards to assess the health and effectiveness of the QRM process
• Partner with executive leadership, site heads and functional leaders to align QRM priorities with business objectives

Leadership, Influence, and Stakeholder Engagement

• Develop and lead a global network of Risk Leads, Risk Facilitators, Subject Matter Experts, and risk practitioners
• Serve as a senior Quality representative in global governance forums, inspections, and regulatory interactions
• Actively monitor internal and external signals, including audit outcomes, inspection findings, deviations, complaints, and emerging regulatory trends
• Sponsor and lead transformational initiatives that leverage QRM and Lean principles, digital enablement, and innovative practices

Typical People Management Responsibility

• Senior leader of expert teams
• Direct and indirect management of global, cross-functional teams
• Matrix leadership across sites, regions, and functions

Education, Qualifications, Skills, and Experience

Essential

• BS/BA degree with 12+ years or MS/MA/PhD with 10+ years experience in pharmaceutical quality, manufacturing, or a related scientific discipline
• Deep subject matter expertise in Quality Risk Management, with demonstrated success implementing global risk programs
• Extensive experience working across multiple areas of Quality within a regulated pharmaceutical environment
• Proven ability to engage effectively with stakeholders at all levels globally and lead through influence across complex, matrixed, multinational organizations
• Strong strategic thinking, communication, and stakeholder engagement capabilities

Desirable

• Experience leading large-scale Quality or Operations transformation initiatives
• Expertise in Business Process Management, Lean, Six Sigma, or comparable continuous improvement methodologies
• Experience overseeing GxP IT systems and digital enablement of Quality processes
• Strong business acumen with the ability to analyze trends, assess risk, and build compelling business cases