Clinical Quality Operations Manager - Remote

Clinical Quality Operations Manager

In partnership with the Clinical Quality Operations Lead and Head of Clinical Quality Operations, the Clinical Quality Operations Manager is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The Clinical Quality Operations Manager 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.

Responsibilities include:

• Overseeing the strategic implementation of quality by design principles in assigned clinical trials.
• Developing Risk Assessment and Categorization Tools and Quality Plans in partnership with the Clinical Trial Team.
• Performing a TA-level review of quality plans and risk mitigation approaches to identify emerging signals or trends.
• Facilitating and overseeing responses to audit and inspection observations.
• Developing skillsets to recognize and respond to new and emerging risks through the use of technology.
• Building effective working relationships with key stakeholders to ensure role clarity and business effectiveness.
• Contributing to the standardization of Clinical Quality Operations procedures, tools, and templates.
• Ensuring comprehensive oversight of all activities delegated to third parties.

The Clinical Quality Operations Manager is also responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide. The Clinical Quality Operations Manager will work with other therapeutically aligned Clinical Quality Operations Managers to provide comprehensive oversight of the TA. The Clinical Quality Operations Manager will develop, update, and maintain GCP inspection procedures and guidelines within Clinical Quality Operations. The Clinical Quality Operations Manager will contribute to the development and/or revision of company policies, SOPs, and training materials.

The Clinical Quality Operations Manager will ensure that a cross-functional team is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide. The Clinical Quality Operations Manager will act as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management to provide real-time, proactive advice and guidance.

The Clinical Quality Operations Manager will ensure that all actions and commitments related to audits and inspections are implemented in a timely manner. The Clinical Quality Operations Manager will provide guidance and support for Clinical Quality Operations Managers regarding inspections at a country level site that requires a company headquarters input.

Education: B.A./B.S. or M.A./M.S. Degree or equivalent in a relevant health care area. Further formal education in quality management or business management is preferred.

Prerequisites: Minimum of 6 years in clinical research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections. Profound knowledge and comprehension of clinical development programs, clinical trial processes, as well as quality management systems and quality control tools. Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements. Has delivered effective CAPA management solutions. Has worked with risk management tools and processes within the clinical quality framework.