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Executive Director, Research Quality Assurance

2 months ago

Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time
Job Title: Executive Director, Research Quality Assurance

About the Role:

We are seeking an experienced Executive Director to lead our Research Quality Assurance function, ensuring the highest standards of quality and compliance in our research activities. As a key member of our global team, you will be responsible for developing and implementing quality systems, managing risk, and driving continuous improvement.

Key Responsibilities:

  • Develop and implement quality systems and processes to ensure compliance with global regulatory requirements and industry best practices.
  • Lead the development of GLP and GCLP systems, risk management processes, and SOPs for QA activities.
  • Manage and guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external publications, and regulatory authority submissions.
  • Partner with Audit and Compliance QA function to develop compliance and risk criteria.
  • Ensure that laboratories and vendors are assessed and nonconformances are mitigated.
  • Develop and implement metrics to monitor and provide QA oversight of research area.

Requirements:

  • 10+ years of professional expertise within GxP regulated activities and QA leadership positions.
  • Broad understanding of global expectations of Health Authorities in the GxP area.
  • Proven expertise within Quality Assurance Research to support Global Research QA.
  • Proven ability to lead and influence others within a global/matrix environment.
  • Strong communications skills, written and oral.

What We Offer:

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.