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Executive Director, Clinical Quality Assurance, R&D Quality

2 months ago

Akron, Ohio, United States Bristol-Myers Squibb Full time
Job Summary

We are seeking an experienced Executive Director to lead our Clinical Quality Assurance function and ensure the highest standards of quality and compliance in clinical research and related activities.

Key Responsibilities
  • Develop and implement quality assurance strategies to ensure compliance with regulatory requirements and company standards.
  • Lead the Clinical Quality Assurance function, providing strategic direction and oversight.
  • Oversee the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and processes/systems.
  • Ensure rapid communication and escalation of quality issues to Health Authorities, business partners, and senior management.
  • Lead vendor quality oversight activities and manage external quality.
  • Develop quality strategies for new clinical trial technology and approaches.
  • Oversee the development and maintenance of an effective inspection management framework supporting clinical trials.
  • Provide leadership and oversight for GCP Inspections.
  • Ensure timely identification, investigation, and resolution of quality issues and non-compliances.
  • Partner with RBQM in the development of the Quality Narrative.
  • Collaborate with Drug Development and other departments to support clinical programs and ensure quality and compliance.
  • Engage with executive management and cross-functional business partners to identify areas of greatest compliance risk.
  • Provide leadership, guidance, development, and coaching to the CQA team.
  • Ensure CQA team are trained and qualified to perform audit and inspection-related activities.
  • Attract, develop, and retain high-quality talent within the organization.
  • Monitor and interpret regulatory trends and changes.
  • Represent the company in interactions with regulatory agencies.
  • Develop and deliver training programs to enhance quality awareness and compliance across the organization.
  • Prepare and present quality metrics and reports to senior management and other stakeholders.
Requirements
  • Minimum of BA/BS degree or in a life science discipline; advanced education preferred.
  • Minimum 20 years Quality experience or relevant BioPharma experience, with demonstrated experience in R&D and R&D Quality roles.
  • Extensive knowledge of GCP, ICH guidelines, and global regulatory requirements.
  • Proven experience in leading and managing quality assurance teams.
  • Strong analytical, problem-solving, and decision-making skills.
  • Communicates professionally, clearly, concisely, and consistently both verbally and in writing to internal and external customers.
  • Experience with regulatory inspections and interactions with regulatory agencies.
  • Strong leadership and organizational skills, with a commitment to fostering a culture of quality and compliance.
  • Previous experience dealing with regulatory agencies in policy development, inspections, investigations, and audits.
  • Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.
  • Ability to develop/translate long-range strategic plans into short-range operational processes/systems/goals and ability to make sound decisions/recommendations with a global perspective.
  • Experience in managing teams, providing coaching, development, and mentoring to employees.
  • Broad understanding of digital and data, including AI, automation, advanced analytics, etc.
  • Proven problem-solving skills to prevent and overcome complex process and quality-related issues.
  • Embraces complexity but strives for simplicity. Keen focus on phase-appropriate and risk-based scientific decision-making.
  • Creates a vision for the future by spotting strategic opportunities for breakthrough performance. Translates the case for change into actionable plans for the organization.
  • Demonstrates smart risk-taking and personal resilience when implementing change. Enables others to navigate change with confidence and in sustainable ways.