Senior Director, Global Process Owner - Quality Risk Management

Role Summary

Senior Director, Global Process Owner for Quality Risk Management. Lead the global quality system for Quality Risk Management, provide strategic oversight for the QRM process, and drive standardization and compliance across the enterprise.

Responsibilities

• Establish and maintain the global quality system for QRM to drive standardization globally.
• Own the Global Standards, Processes, Practices, Trainings, and implementation tools; ensure alignment with regulatory, industry, and company expectations.
• Provide governance, lead improvement initiatives, and foster a robust compliance mindset.
• Ensure processes are executed consistently across the organization; monitor signals to drive continuous improvement.
• Lead IT applications and analytical tools supporting QRM; facilitate reporting and analytics.
• Define global metrics to drive end-to-end performance; monitor and provide insights to inform decision making.
• Develop and mentor a community of cross-functional SMEs; collaborate to deepen knowledge of processes and tools.
• Collaborate with enterprise-wide teams on standardized global business processes.
• Ensure inspection readiness; interact with Health Authorities during inspections and draft responses as needed.
• Engage with external organizations to monitor policy changes and influence quality-related regulatory requirements.
• Own the global risk log and risk register; ensure key quality risks are mitigated.
• Support Quality Maturity Model initiatives to integrate QRM principles into routine processes.

Qualifications

• 10+ years in the pharmaceutical industry in GxP roles, with several years in Quality.
• Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.

Skills

• Proven ability to work in a matrixed organization; influence across diverse teams.
• Strategic thinking with ability to execute decisions while balancing priorities.
• Structured problem-solving to address operational challenges; innovative solutions.
• Data-driven ability to drive process improvements and strategic decisions.
• Change agility to lead others through change and ambiguity.
• Excellent teamwork, interpersonal, and communication skills across levels.
• Ability to develop scalable, standardized processes; improve efficiency and reduce complexity.
• Influential leadership with experience engaging senior-level leads.
• Decision-making with balance of speed, quality, and risk to deliver results.
• Governance establishment and proactive handling of quality and regulatory risks.
• People management experience.
• Expertise in global regulatory standards and frameworks.
• Experience with QRM tools and maintenance of risk logs/registers.
• Experience in Clinical Operations/Development, Pharmacovigilance, Product R&D, or Commercial Manufacturing is preferred.

Education

• Bachelor’s degree in Natural Science, Engineering, Pharmacy, or related Life Science field.

Additional Requirements

• Available to travel domestically and internationally as required.
• Fluent in English; additional languages recommended.