Director of Clinical Quality Assurance

4 weeks ago


Maidenhead, Windsor and Maidenhead, United Kingdom AbbVie Full time
Job Description

AbbVie is seeking a highly skilled Clinical Quality Assurance Director to lead our Clinical QA team in Europe. As a key member of our organization, you will be responsible for ensuring the quality of our clinical trials and investigations, while maintaining compliance with global and regional regulations.

Key Responsibilities
  • Lead a team of quality assurance professionals to drive compliance with global and regional guidance and regulations.
  • Develop and implement quality strategies and solutions to support effective and timely responses to compliance issues and audit/inspection findings.
  • Collaborate with business partners to ensure quality is integrated at all stages of process development.
  • Provide expert technical quality support and consultation to R&D colleagues and Development Operations business partners.
  • Act as the primary CQA contact for Regulatory Agency GCP country sponsor and site inspections in 35+ countries in Europe.
Qualifications
  • Bachelor's degree in a relevant field, such as biology, nursing, or pharmacy.
  • Minimum 5 years of experience in Clinical Research, Quality Assurance, or Compliance roles.
  • Proven leadership skills with direct reporting and matrixed environments.
  • Ability to evaluate the quality of affiliate clinical operations and make judgments and assessments of performance under regulatory inspections.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.



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