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Executive Director, Global Clinical Quality Assurance Leader

2 months ago

Trenton, New Jersey, United States Proclinical Staffing Full time
Job Summary

We are seeking a highly experienced and skilled Executive Director to lead our Global Clinical Quality Assurance department. As a key member of our team, you will be responsible for developing and implementing global quality assurance policies and procedures that comply with Good Clinical Practice (GCP) and regulatory requirements.

Key Responsibilities
  • Develop and Implement Quality Assurance Policies
    • Design and implement global quality assurance policies and procedures that meet GCP and regulatory requirements.
    • Ensure compliance with regulatory standards and best practices.
  • Lead Audit Programs
    • Develop and implement comprehensive audit programs to ensure adherence to GCP and regulatory compliance.
    • Lead and manage routine and for-cause audits to identify and address quality issues.
  • Regulatory Compliance
    • Oversee preparation and response strategies for regulatory inspections.
    • Collaborate with regulatory affairs and clinical operations to align quality assurance strategies with overall clinical development plans.
  • Quality Process Improvement
    • Ensure continuous update and adaptation of quality processes to reflect changes in regulatory standards and best practices.
    • Identify and implement process improvements to enhance quality and efficiency.
  • Stakeholder Communication
    • Serve as the primary quality assurance liaison with regulatory authorities, partners, and internal stakeholders.
    • Ensure transparent communication and collaboration on quality-related matters.
Requirements
  • Education
    • Bachelor's degree in Life Sciences, Pharmacy, or related field.
    • Advanced degree (MS or PhD) preferred.
  • Experience
    • Extensive experience in clinical quality assurance within a global organization.
    • Experience with GCP-focused work and managing international audits and inspections.
    • Certification in Quality Assurance (CQA or RQAP-GCP) preferred.
  • Skills
    • Exceptional leadership and organizational skills.
    • Strong analytical skills and a methodical approach to problem resolution.
    • Excellent communication skills, capable of effectively presenting and discussing complex issues.
    • Strong project management skills and demonstrated ability to look at the big picture when making decisions.