Assoc Director, Quality Lead, Data Management FSP

Location: Dublin, Ireland; other listed locations include Centurion, Bloemfontein and Bellville, South Africa, and Reading, United Kingdom. No relocation opportunities are provided.

Company

Provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Lead quality management processes across a customer Data Management Functional Service Partnership and act as the primary owner of quality incidents in hirify.global and customer quality systems.
• Coordinate investigations, direct functional leads and subject-matter experts, establish root causes using investigation principles such as the 5 Whys, and document effective CAPAs.
• Track partnership-level investigations, drive portfolio-level CAPA implementation, and escalate issues when the required support is unavailable.
• Analyze aggregated quality incident data, identify recurring trends, communicate findings to internal stakeholders and sponsors, and report CAPA progress.
• Monitor Trial Master File compliance, support audit and inspection readiness, and conduct internal Data Management and eTMF quality reviews when required.
• Provide quality incident and process improvement expertise, monitor quality KPIs when required, and maintain knowledge of applicable regulatory and sponsor guidelines.

Requirements

• Bachelor's degree or educational equivalent in clinical, biological or mathematical sciences, a related field, or a nursing qualification with 10 years of relevant work experience including substantial people management experience; an equivalent combination of education, training and experience is also accepted.
• Advanced knowledge of Data Management processes, systems, and clinical drug development.
• Strong leadership, staff management, and team development skills.
• Proven project management experience with the ability to manage multiple priorities.
• Solid financial management, budgeting, and business acumen.
• Excellent communication, presentation, negotiation, and stakeholder management skills, including experience building and maintaining senior-level client and customer relationships.
• Strong problem-solving, decision-making, and organizational abilities.
• Ability to work effectively in a matrix environment and deliver results through collaboration and influence.
• Technical programming skills and experience producing Data Management deliverables; demonstrated ownership, initiative, solutions-focused behavior, and the ability to remain confident, diplomatic, and effective in challenging situations.
• High School Diploma or equivalent required.

Culture & Benefits

• Full-time employment.
• No relocation opportunities are provided.
• Work involves collaboration across a matrix environment and engagement with customers, sponsors, functional leads, and senior stakeholders.