Clinical Quality Operations, Oncology III

Job Description

Our Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

It is business critical that our Company receives consistent, accurate, high‑quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area, including operational quality management and inspection management activities.

The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed.

The incumbent will be accountable for the development of quality plans to implement quality by design within clinical development programs, using a risk‑based approach.

The incumbent will be accountable for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, managing and following up on regulatory inspections.

• Accountable for overseeing the strategic implementation of quality by design principles in assigned clinical trials.
• Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT.
• Collectively and periodically perform a TA‑level review of quality plans and risk mitigation approaches to identify emerging signals or trends and provide feedback to the CQOL and Head of CQO.
• Facilitate and oversee the responses to audit and inspection observations. Work with peers to analyze data across therapy areas to identify signals and trends, then develop and implement process improvement strategies.
• Develop skillsets to recognize and respond to new and emerging risks through technology, maintaining profound knowledge of Good Clinical Practice with respect to digital data management.
• Build and enable effective working relationships with key stakeholders to ensure role clarity and business effectiveness, including partnership with QA, Clinical Development, study teams, global business functions and regional study management.
• Ensure comprehensive oversight of all activities delegated to third parties.

The CQOM is responsible for maintaining current regulatory inspection knowledge related to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the U.S. Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, and other established and emerging authorities.

• Work with other therapeutically aligned CQOM to provide comprehensive oversight of the TA, maintaining awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.
• Ensure a cross‑functional team (Quality & Continuous Improvement, GCTO Country Operations, other GCTO functional areas, PV, GRACS, IT, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection worldwide.
• Collaborate with the Global Inspection Coordinator and Head of CQO to maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and CAPAs worldwide.
• Develop the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable cross‑functional team.

• Ensure all actions and commitments related to audits and inspections are implemented in a timely manner. Track all inspection CAPAs and regulatory commitments and check evidence of completion.
• Maintain a repository of evidence containing CAPA completion documentation and other definitive inspection documentation.
• Provide guidance and support for CCQMs regarding inspections…