Assoc Director, Quality Lead, Data Management FSP

IQVIA; Dublin; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

IQVIA is seeking a Quality Lead to manage quality management processes within the Data Management function, ensuring databases meet customer requirements and regulatory expectations. You will own quality incidents, coordinate investigations across functional leads, drive CAPAs, monitor TMF compliance, and report progress to stakeholders, ultimately supporting audit readiness.

Responsibilities include leading investigations, escalating when needed, and ensuring high-quality deliverables through

Qualifications

• Advanced knowledge of Data Management processes, systems, and clinical drug development.
• Strong leadership, staff management, and team development skills.
• Proven project management experience with ability to manage multiple priorities.
• Excellent communication, negotiation, and stakeholder management skills.
• Experience building and maintaining client relationships at a senior level.

Responsibilities

• Lead Quality Management processes within a Data Management team.
• Act as primary issue owner for QIs and coordinate investigations.
• Direct functional leads/SMEs to identify root causes and CAPAs.
• Escalate to Leadership when cross-functional support is needed.
• Monitor TMF compliance and support audit readiness.
• Provide updates on CAPA progress to customers and stakeholders.

Skills

Data Management

Leadership

Project management

Budgeting

Communication

Stakeholder management

Problem-solving

Organizational abilities

Client relationships

Collaboration

Initiative

Quality deliverables

Programming skills

Education

Bachelor's degree or equivalent (clinical/biological/mathematical sciences) or nursing qualification

Job description

**Quality Lead Job Overview** Lead Quality Management processes in a team of Data Management professionals to efficiently produce databases that meet customer requirements. **Quality Lead Functions** • Act as the primary issue owner and centralized manager for any quality incidents (QI) logged in the IQVIA Quality Management System or Customer Quality System across the Customer Data Management Functional Service Partnership (FSP). • Coordinate targeted investigation for QIs; includes making targeted resource requests of the relevant Functional Leads to support the QI investigations • Direct the appropriate functional lead member(s)/SMEs in the investigation, utilizing quality issue investigation principles e.g. 5 whys to ensure the team establish the correct root cause and effective CAPAs, bringing together all inputs and documenting the QI investigation summary and CAPA clearly • Escalating to Leadership Team where the required support is not available from within the functions to establish the correct root cause and/or CAPA in a timely manner • Conduct and track partnership level investigations, summarizing outputs in the Quality Management System and drive portfolio level CAPA implementation (with support from the Functional Lead from the relevant function) • Review aggregated QI data and performs analysis and identification of trends at portfolio level and ensure that recurring findings/errors are communicated internally and to the Sponsor • Provides updates on CAPA progress to Customer and share corrective/preventative actions for review and discussion where appropriate • Negotiation with customer where different views exist on root cause and ownership of quality issues to ensure that IQVIA’s position is explained clearly with rationale, escalating where appropriate • Monitor Trial Master File (TMF) compliance across the portfolio supporting audit/inspection readiness to supplement functional accountability • May conduct internal Data Management Quality Reviews, including eTMF Reviews, as part of the portfolio Quality Management Team in order to fulfil business unit, customer and regulatory authority requirements and expectations • May monitor portfolio level customer Key Performance Indicators (KPIs) for quality to supplement functional leadership management and reporting of quality • Provide leadership and innovative ideas to the portfolio from a quality incident perspective • Serve as Subject Matter Expert, providing quality incident and process improvement expertise to CDM management • Maintain working knowledge of current applicable regulatory and Sponsor guidelines and related review techniques **Qualifications**• Bachelor's Degree Or educational equivalence, in clinical, biological or mathematical sciences or related field, or nursing qualification with 10 years of relevant work experience including substantial people management experience; or equivalent combination of education, training and experience **Requirements** 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.Strong problem-solving, decision-making, and organizational abilities.Experience building and maintaining client and customer relationships at a senior level.Ability to work effectively in a matrix environment and deliver results through collaboration and influence.Demonstrated ownership, initiative, and a solutions-focused approach.Technical programming skills and experience producing Data Management deliverables.Ability to remain confident, diplomatic, and effective when managing challenging situations.High School Diploma or equivalent required.