Associate Director, Quality Lead, Data Management Fsp

Iqvia; Reading; On-site; GBP 90,000 - 120,000; Full time

Job summary

IQVIA is seeking a Quality Lead to head Quality Management in our Data Management team in Reading. You will drive investigations, CAPAs and ensure TMF/compliance across the portfolio to meet customer requirements.

You will coordinate cross-functional teams, mentor SMEs, leverage quality principles (5 whys, root-cause analysis) and partner with leadership to deliver robust quality outcomes in a fast-paced environment.

Qualifications

• Advanced knowledge of Data Management processes, systems, and clinical drug development.
• Strong leadership and people-management 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 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.

Responsibilities

• Act as primary owner for quality incidents in IQVIA QA systems.
• Coordinate QI investigations and request resources from Functional Leads.
• Direct SMEs using quality methods (5 whys) to identify root causes and CAPA; document summaries.
• Escalate to Leadership when needed to obtain timely root cause and CAPA.
• Lead partnership-level investigations and drive portfolio CAPAs with functional support.
• Analyze QI data for trends and report to Sponsor.
• Update Customer on CAPA progress and actions.
• Negotiate with customer on root cause ownership and rationale.
• Monitor TMF compliance for audit readiness.
• Conduct internal Data Management quality reviews, including eTMF.
• Monitor customer KPIs for quality at portfolio level.
• Provide leadership and innovative ideas from quality incidents.
• Act as SME for quality incidents and process improvement in CDM management.
• Maintain knowledge of regulatory guidelines and review techniques.

Skills

Quality incident management

CAPA management

Root cause analysis

5 whys

Data Management

TMF compliance

Stakeholder management

Project leadership

Cross-functional leadership

Regulatory knowledge

Education

Bachelor's Degree in clinical/biological/mathematical sciences or nursing with 10+ years leadership experience

Tools

Quality Management System (QMS)

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.