Assoc Director, Quality Lead, Data Management FSP

IQVIA; Dublin; On-site; EUR 120,000 - 160,000; Full time

Job summary

IQVIA is seeking a Quality Lead to head the Quality Management processes within the Data Management function. You will oversee incident management, drive investigations, CAPA development, and ensure TMF compliance across the portfolio.

You will coordinate with functional leads to apply root-cause techniques, monitor KPIs and communicate with customers. A strong background in data management, leadership and regulatory awareness is required.

Qualifications

• Bachelor's degree or educational equivalence in clinical, biological or mathematical sciences or related field.
• Advanced knowledge of Data Management processes, systems and clinical drug development.
• Strong leadership, staff management and project delivery capabilities.
• Excellent communication and stakeholder management across a matrix organization.

Responsibilities

• Act as the primary owner for quality incidents logged in IQVIA systems.
• Coordinate investigations with Functional Leads and drive CAPA implementation.
• Guide SMEs in using root-cause methods to determine corrective actions.
• Escalate to leadership when required to resolve complex quality issues.
• Monitor TMF compliance and support audit readiness across portfolios.
• Summarize investigations and share CAPA outcomes with customers.

Skills

Leadership

Project management

Stakeholder mgmt

Quality management

Data management

Communication

Problem solving

CAPA

Regulatory knowledge

Programming skills

Education

Bachelor's Degree

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.

No relocation opportunities provided

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law.

We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.

No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for growing your career with us.