Senior Director, Global Process Owner - Quality Risk Management

Role Summary

The Senior Director, Global Process Owner for Quality Risk Management leads the global Quality Risk Management (QRM) program within the Global Quality Systems team. They establish and maintain the global quality system for QRM, provide strategic oversight of the global QRM process, and lead the QRM Community of Practice. They collaborate with manufacturing facilities, suppliers, regulatory, development, and other functions to ensure compliance with country agency standards and industry practices, and drive continuous improvement across 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 and ensure they are designed according to regulatory, industry and company expectations.
• Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset.
• Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
• Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics.
• Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.
• Monitor performance metrics, report and provide insights to inform decision making to drive further improvements.
• Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools.
• Actively collaborate with enterprise-wide teams on standardized global business processes.
• As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.
• Actively engage in external organizations and industry organizations to monitor policy changes for regulatory/external environments and advocate/influence quality-related policies and regulatory requirements related to Quality Risk Management.
• Own the global risk log and global risk register, ensuring that key quality risks across the enterprise are actively being mitigated.
• Support the Quality Maturity Model initiatives by actively enhancing the cultural mindset across the enterprise to integrate QRM principles into routine processes.

Qualifications

• Required: 10+ years’ experience in the pharmaceutical industry in GxP roles, with several years Quality experience.
• Required: Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.
• Preferred: Proven ability to work in a matrixed organization with diverse teams and influencing areas not under direct control.
• Preferred: Strong strategic thinking capability with a focus on executing strategic decisions while balancing conflicting priorities.
• Preferred: Proficiency in addressing operational challenges through structured approaches and innovative solutions.
• Preferred: Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data.
• Preferred: Demonstrated change agility in anticipating and leading others through change and ambiguity.
• Preferred: Excellent teamwork, interpersonal, and communication skills; ability to collaborate at all levels.
• Preferred: Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity.
• Preferred: Demonstrated influential leadership with senior-level functional leads.
• Preferred: Strong leadership capability to balance speed, quality, and risk to deliver results.
• Preferred: Experience establishing governance structures and addressing quality/regulatory risks; people management experience.
• Preferred: Expertise in navigating global regulatory standards and frameworks; experience with QRM tools and maintaining a risk log/register.
• Preferred: Experience in Clinical Operations/Development, Pharmacovigilance, Product R&D, or Commercial Manufacturing.

Education

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

Additional Requirements

• Available to travel (domestic and international) when required.
• Fluent in English; additional languages recommended.