Executive Director, Clinical Quality Assurance, R&D Quality

3 days ago

Summit, New Jersey, United States Bristol-Myers Squibb Full time

Job Summary

The Executive Director, Clinical Quality Assurance, R&D Quality is a key leader on the R&D Quality Leadership Team responsible for leading the Clinical Quality Assurance function and ensuring the highest standards of quality and compliance in clinical research and related activities.

This role is responsible for developing and implementing quality assurance strategies, including therapeutic area, process, and vendor audit and inspection strategies to ensure compliance with regulatory requirements and company standards.

The Executive Director will work closely with cross-functional teams to support clinical development and ensure the integrity and quality of clinical data and clinical trial subject safety.

This leader will sit on key functional area leadership team(s) and also chair key clinical quality councils.

The Executive Director will provide credible compliance advice and guidance as well as manage and communicate quality and compliance risks and mitigations to respective management boards.

This role is a key contributor in advancing our overall Global Quality vision and strategy.

Key Responsibilities

  • Lead the Clinical Quality Assurance function, providing strategic direction and oversight.
  • Develop, implement, and maintain quality assurance policies, procedures, and systems to ensure compliance with GCP, ICH guidelines, and regulatory requirements.
  • Translate risk factors into clinical quality assurance oversight plans, including internal and external audit strategies and inspection readiness/management strategies.
  • Oversee the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and processes/systems, including for-cause and directed activities.
  • Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to Health Authorities, business partners, and senior management.
  • Lead vendor quality oversight activities and manage external quality (e.g., quality agreements with CROs, set vendor quality councils, etc.).
  • Develop quality strategies for new clinical trial technology and approaches (e.g., decentralized trials, real-world evidence, digital health, etc.).
  • Oversee the development and maintenance of an effective inspection management framework supporting clinical trials.
  • Provide leadership and oversight for GCP Inspections ensuring effective readiness, preparation, management, and response development and action closure.
  • Ensure timely identification, investigation, and resolution of quality issues and non-compliances.
  • Partner with RBQM in the development of the Quality Narrative, specifically developing and contributing the audit/inspection portion.
  • 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 and obtain information and feedback relevant to process improvement, drive issue resolution.
  • Provide leadership, guidance, development, and coaching to the CQA team, fostering a culture of quality and continuous improvement.
  • 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, and ensure the company's clinical quality systems are updated accordingly.
  • 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.
  • Lead and chair clinical quality council, partnering with RBQM to ensure relevant clinical trial risks are effectively managed and overseen.
  • Manage a fiscally responsible department budget including operating expenses, staffing level, and outside collaborations.
  • Engage and influence in external industry consortiums and benchmark opportunities.

Qualifications & Experience

  • 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 for appropriate strategy setting, decision making, and quality oversight to ensure BMS complies with 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; excellent presentation skills for compelling peer and Senior Management communication.
  • 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 global perspective.
  • Experience in managing teams, providing coaching, development, and mentoring to employees.
  • Understands the big picture, beyond their own functional area. Enterprise thinker.
  • 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.

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