Director, Quality Risk Management
About The Position
The Director, Quality Risk Management (QRM) is an enterprise Quality leader responsible for defining, governing, and advancing the global QRM strategy. The role supports the Executive Director of Risk and Proactive Quality and has direct leadership accountability for the QRM process across PDM. It provides strategic direction and oversight to embed QRM principles, risk-based thinking, and proactive quality approaches throughout the Pharmaceutical Quality System and operations. The Director designs, implements, and sustains compliant, scalable, and efficient global processes that support early risk identification, effective mitigation, and continuous improvement in alignment with cGMP, ICH, and evolving global regulatory expectations. As a member of the Extended Central Quality leadership team, the role drives cultural transformation toward a systemic, proactive, and learning-oriented quality organization, supporting sound decision-making, operational excellence, and sustained regulatory compliance across a multinational environment. The role has enterprise-wide accountability spanning global markets and operating regions, and leads expert teams directly, indirectly, and through matrix leadership across sites, regions, and functions. It regularly engages across countries and cultures.
Requirements
- BS/BA degree and 12 or more years of experience in pharmaceutical quality, manufacturing, or a related scientific discipline; alternatively, an MS/MA/PhD and 10 or more years of experience.
- Deep subject matter expertise in Quality Risk Management, with demonstrated success implementing global risk programs.
- Extensive experience working across multiple areas of Quality in a regulated pharmaceutical environment.
- Proven ability to engage stakeholders globally at all levels and lead through influence in complex, matrixed, multinational organizations.
- Strong strategic thinking, communication, and stakeholder engagement capabilities.
Nice To Haves
- 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, including the ability to analyze trends, assess risk, and build compelling business cases.
Responsibilities
- Define and execute the global Quality Risk Management framework, with enterprise accountability for strategy, standards, performance, and continuous improvement.
- Design, own, and approve global QRM standards, policies, procedures, and training aligned with cGMP, ICH, and applicable regulatory expectations.
- Advance organizational risk maturity, capability, and culture by embedding proactive risk approaches and risk-based thinking into decision-making and GxP processes.
- Drive, implement, and monitor QRM Master Plans and living Risk Assessment Portfolios across PDM.
- Integrate and align Risk and Change Management processes across the Pharmaceutical Quality System and related business processes.
- Integrate Proactive HOP processes and human-centric risk mitigation into quality and operational processes.
- Collaborate with the Medical Device and Combination Product team to align and harmonize QRM and MDCP risk management frameworks where applicable.
- Oversee the enterprise Quality Risk Register and develop the Operations Quality risk profile for senior leadership and management review forums.
- Link Quality Risk Management requirements with broader enterprise and operational risk management frameworks.
- Serve as Module Business Process Lead for the electronic QRM system, such as the GVault Risk Module, maintaining and enhancing its use across QRM activities.
- Collaborate with Technical, Regulatory, Safety, and Operations partners to manage product, process, vendor, and systems risks within GxP.
- Lead and contribute to QRM projects and initiatives, including process and system enhancements and continuous improvement.
- Define, implement, and monitor metrics, KPIs, and dashboards to assess QRM process health and effectiveness.
- Partner with executive leadership, site heads, and functional leaders to align QRM priorities with business objectives.
- Develop and lead a global network of Risk Leads, Risk Facilitators, Subject Matter Experts, and risk practitioners through direct, matrix, and influence-based leadership.
- Represent Quality at global governance forums, inspections, and regulatory interactions related to QRM.
- Monitor internal and external signals, including audit outcomes, inspection findings, deviations, complaints, and regulatory trends, to inform strategy and priorities.
- Sponsor and lead transformational initiatives using QRM and Lean principles, digital enablement, and innovative practices to improve process effectiveness and efficiency.
- Lead and manage expert teams, including direct and indirect management of global cross-functional teams and matrix leadership across sites, regions, and functions.
Benefits
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance
- May be eligible for a discretionary annual bonus
- May be eligible for discretionary stock-based long-term incentives, depending on role
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What This Job Offers
Job Type
Full-time
Career Level
Director
