Associate Director – Quality Lead, Data Management

Iqvia

Reading

On-site

GBP 90,000 - 120,000

Full time

10 days ago

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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

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.

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