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AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Head of Audit, Clinical Audit (EMEA)

London, United Kingdom Req ID 2206838 Category Quality Assurance Division AbbVie

Head of Audit, Clinical Audit (EMEA)

  • Preferred location: UK or Germany, other locations in Europe considered
  • Join as part of the global Clinical Audit Leadership team
  • An extensive benefits package including annual bonus, and opportunities to progress and develop your career at AbbVie

Role Objective:

Leads a high performing team delivering on the Clinical Audit strategy across Europe, Middle East and Africa, to assure the quality and compliance of AbbVie clinical trials and studies in this region.

Key Responsibilities:

  • Line manage a team of Clinical Auditors; driving high performance and ensuring cross-functional collaboration to build-in quality as part of AbbVie processes
  • Contribute to the development of the global Clinical Audit strategy, implementing at a regional level
  • Conduct more complex audits, work with auditees on any corrective actions to maintain quality standards
  • Collaborate with QA colleagues and business partners to deliver innovative quality strategies, support effective solutions to compliance issues and drive continuous improvement
  • Provide expert advice and support on clinical regulations, guidance, and expectations
  • Promote continuous education on quality and clinical standards to AbbVie employees
Qualifications:

Experience:

  • Pharmaceutical or Regulatory Authority background, with substantial experience in clinical development/research, clinical trials regulatory affairs, regulatory inspections and/or clinical quality assurance
  • Preferred demonstrated experience in people leadership
  • Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
  • Experience in delivering projects with a regional or global scope

Competencies:

  • Advanced knowledge of clinical quality management principles and recognized standards including ICH-GCP
  • Able to take initiative, manage complex decisions as a collaborative leader
  • Demonstrated examples of establishing a clear direction, with a strategic mindset
  • Willingness to perform international travel (up to 25%)
Travel: Yes, 25 % of the Time
Job Type: Experienced
Schedule: Full-time
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