Senior Director, Global Process Owner - Quality Risk Management

Role Summary

Senior Director, Global Process Owner - Quality Risk Management. Establishes and maintains the global quality system for Quality Risk Management, providing strategic oversight and leading a global community of practice and key initiatives within the Quality System.

Responsibilities

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

Qualifications

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

Skills

• Ability to work in a matrixed organization with diverse teams and influence areas not under direct control.
• Strategic thinking with the ability to execute decisions while balancing priorities.
• Structured approach to addressing operational challenges and innovative solutions.
• Data-driven process improvement and decision-making.
• Change agility and ability to lead others through change and ambiguity.
• Strong teamwork, interpersonal, and communication skills across all levels.
• Experience developing scalable, standardized processes across global operations.
• Influential leadership with senior-level engagement.
• Decision-making leadership balancing speed, quality, and risk to deliver value.
• Governance establishment and proactive risk management in quality/regulatory domains.
• People management experience.
• Experience navigating global regulatory standards and frameworks.
• Experience with QRM tools and risk log maintenance; familiarity with Clinical Operations/Development, Pharmacovigilance, Product R&D, or Commercial Manufacturing preferred.

Education

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

Additional Requirements

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