Senior Director of Quality

Overview

In this role you lead the Speke Manufacturing quality organization, steering quality strategy, compliance, and product quality across the site. You collaborate with R&D and cross-functional partners to develop and launch products, while ensuring regulatory readiness and robust quality systems. You drive improvement, risk management, and supplier governance to support site goals and business success. You will lead a ~50-person quality team and report into global quality leadership.

Responsibilities

• Oversee Quality Management for regulatory compliance and site performance
• Lead and resolve quality and technical issues per global standards
• Escalate critical issues to management and ensure timely resolution
• Notify VMD Rapid Alert network for product defects impacting safety or quality
• Develop and implement Quality Strategy, Site Quality Plans, and Q plans
• Prepare for and support HA inspections (PAI and others)
• Track GMP follow-ups from audits/inspections and action them
• Prepare/manage the quality budget and resource allocations
• Govern quality KPIs, metrics, and quality system signals; initiate corrective actions
• Support deployment of operational excellence to improve lab/site productivity
• Collaborate with Manufacturing and Supply Chain to meet quality/objectives
• Recruit and develop global talent; build succession plans and high-performance culture
• Deploy Quality Risk Management techniques and mitigate risk with Manufacturing/Supply
• Maintain Quality Assurance Agreements with suppliers per Elanco requirements
• Provide governance and status updates through management reviews
• Participate in cross-functional quality strategy development and implementation
• Mentor staff and define development goals for direct reports and critical roles
• Ensure readiness for transfers, launches, and due-diligence projects

Key requirements

• BS in a scientific field
• 5+ years in QA with at least 10 years in management or project leadership
• Pharmaceutical industry experience with QA Operations, Manufacturing, QC
• Strong knowledge of global cGMP and regulatory requirements for commercial DP processes
• Proven track record with inspections (VMD, FDA and others)
• Experience in QA leadership at site and network levels
• Strong risk management and problem-solving capabilities
• Ability to manage budgets and cross-functional projects

• Leadership and people development
• Stakeholder collaboration
• Strategic thinking and planning
• QA Operations
• Quality Assurance and Quality Control
• Quality Systems and governance

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