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 (CQOM) is responsible for the execution of operational quality activities within the assigned therapeutic area. This role includes overseeing headquarters clinical quality operations and supporting clinical trial teams to embed quality into our company's sponsored trials, ensure adequate vendor oversight, and address any quality issues as needed. The CQOM will develop quality plans to implement quality by design within clinical development programs, using a risk-based approach. The CQOM will also be responsible for the overall strategy for maintaining ongoing inspection readiness and preparing for, managing, and following up on regulatory inspections.

The responsibilities of the CQOM 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 therapy area-level review of quality plans and risk mitigation approaches to identify emerging signals or trends and provide relevant feedback to the Clinical Quality Operations Lead and Head of Clinical Quality Operations.
• Facilitating and overseeing responses to audit and inspection observations.
• Developing and maintaining a profound knowledge of Good Clinical Practice with respect to digital data management, including the use of novel technology within clinical trials.
• Building and enabling 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 to ensure consistency and seamless progression through the study lifecycle.
• Ensuring comprehensive oversight of all activities delegated to third parties, including vendor oversight and development, review, and revision of quality agreements.

The CQOM is also responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide. The CQOM will work with the Clinical Quality Operations Lead to provide comprehensive oversight of the therapy area, maintain awareness of filing schedules, potential future inspections, and ongoing inspection preparation activity. The CQOM will also develop, update, and maintain GCP inspection procedures and guidelines within Clinical Quality Operations, contribute to the development and/or revision of company policies, SOPs, and training materials, and develop the strategy for management and support for GCP inspections of company products.

The CQOM will ensure that all actions and commitments related to audits and inspections are implemented in a timely manner, track all inspection CAPA and regulatory commitments, and provide guidance and support for clinical quality operations managers regarding inspections at a country level sites that require a company headquarters input.

Education requirements include a 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 include a minimum of 6 years in clinical research, including at least 2 years in developing and managing clinical quality systems and management of regulatory inspections. The CQOM must have profound knowledge and comprehension of clinical development programs, clinical trial processes, quality management systems, and quality control tools. The CQOM must also have expert knowledge of GCP/ICH and worldwide regulatory health authority requirements and have delivered effective CAPA management solutions. The CQOM must have experience working with risk management tools and processes within the clinical quality framework.

Skills required include superior oral and written communication skills in an international environment, ability to manage and develop others, excellent project management and organizational skills, excellent teamwork and leadership skills, including conflict resolution expertise and discretion, ability to lead cross-functional teams of business professionals within and outside the research division, ability to act urgently for worldwide health authority inspection matters, and ability to analyze, interpret, and solve complex problems.