drjobs Senior Manager, IT Compliance & Validation (Life Sciences)

Senior Manager, IT Compliance & Validation (Life Sciences)

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1 Vacancy
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Job Location drjobs

Dublin - Ireland

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

About the Role

IQVIA is seeking a strategic and experiencedSenior Manager IT Compliance & Validationto serve as a key liaison between our sponsors internal IT product teams and enterprise quality assurance. This high-impact role ensures that our technology solutions meet global regulatory requirements and align with sponsor expectations across the product lifecycle.

You will lead sponsor-facing compliance initiatives advise on GxP-regulated system design and validation and play a critical role in fulfilling IQVIAs compliance commitments in a dynamic regulated environment.

Key Responsibilities

Sponsor Engagement & Relationship Management

  • Act as the primary IT Compliance & Validation lead for assigned sponsors or clients.
  • Define and execute sponsor oversight and engagement strategies to meet compliance commitments.
  • Represent IQVIAs Quality Management in sponsor meetings audits and inspections.
  • Serve as the escalation point for sponsor-reported IT compliance and quality issues.

IT Compliance & Validation Leadership

  • Guide product teams on regulatory requirements and validation strategies for GxP-regulated systems.
  • Lead system compliance assessments risk evaluations and validation planning.
  • Ensure alignment with IQVIAs Quality Management System and global regulatory standards.

Regulatory Strategy & Risk Management

  • Interpret and apply global regulations (e.g. FDA EMA MHRA 21 CFR Part 11 GxP) to IT systems and processes.
  • Develop validation methodologies and communication strategies for sponsor-facing projects.
  • Partner with QA to ensure vendor compliance and recommend actions to align with sponsor expectations.

Cross-Functional Collaboration

  • Collaborate with IT QA and product teams to ensure validation deliverables are accurate complete and audit-ready.
  • Drive alignment of system lifecycle and validation processes across internal teams.
  • Support the development of compliance KPIs to track partnership effectiveness.

Qualifications & Experience

Must-Have:

  • Bachelors degree in Computer Science Life Sciences Information Systems or related field (Masters preferred).
  • Substantial experience in IT compliance validation or quality roles within life sciences pharma or CROs.
  • Strong knowledge of GxP 21 CFR Part 11 and global regulatory frameworks.
  • Proven experience leading sponsor/client engagements and managing audits or inspections.
  • Excellent communication stakeholder management and documentation skills.

Nice-to-Have:

  • Experience with cloud-based systems and modern validation approaches (e.g. CSA).
  • Familiarity with audit trail review tools or automated validation platforms.
  • Knowledge of Privacy by Design principles and software quality assurance best practices.

Why Join Us

At IQVIA youll be part of a global leader in healthcare data science and technology. Youll work with top-tier clients cutting-edge systems and a team that values innovation compliance and collaboration.

Ready to Apply

If youre passionate about driving compliance excellence in a sponsor-facing role and thrive in a regulated fast-paced environment wed love to hear from you.

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


Required Experience:

Senior Manager

Employment Type

Full-Time

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