Stability Program Manager (Medical Devices)

TL;DR

Stability Program Manager (Medical Devices): Leading the drug stability portfolio for combination products with an accent on stability strategy, regulatory compliance, and cross-functional alignment. Focus on driving execution of stability studies, managing regulatory submissions, and ensuring audit readiness for ICT and PVH portfolios.

Location: Must be based in Galway, Ireland (Hybrid)

Salary: €84,880 - €127,320

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life.

What you will do

• Lead stability program activities for all drug-device combination products across ICT and PVH portfolios.
• Define and execute stability strategies for new product development, sustaining programs, and manufacturing changes.
• Serve as the primary Quality technical SME for drug stability, providing guidance on study design and data interpretation.
• Partner with Regulatory Affairs to support submissions and responses to audits and inspections.
• Maintain integrated stability plans, schedules, and risk assessments to ensure timely delivery.
• Mentor and develop stability team members to strengthen organizational technical depth.

Requirements

• Bachelor's degree with 5+ years of relevant experience or an advanced degree with 3+ years of experience.
• Advanced expertise in drug stability or Quality engineering within a regulated environment.
• Deep understanding of stability study design, protocols, and regulatory expectations for combination products.
• Strong knowledge of Quality systems, Design Controls, and global regulatory requirements.
• Proven ability to lead complex technical workstreams across multiple programs via influence.
• Must be based in or able to work from Galway, Ireland.

Nice to have

• Experience with coronary, peripheral vascular, or other cardiovascular drug-device products.
• Experience working across multiple operating units and manufacturing sites globally.
• Experience defending stability strategies during regulatory audits or notified body reviews.
• Knowledge of analytical testing, laboratory operations, and sample management.

Culture & Benefits

• Competitive salary and a flexible benefits package.
• Eligibility for the hirify.global Incentive Plan (MIP) short-term incentive.
• Opportunity to work in a purpose-driven environment focused on patient outcomes.
• Career growth and professional development within a global healthcare leader.