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 Clinical Quality Operations Manager will be accountable for the development of quality plans to implement quality by design within clinical development programs, using a risk-based approach. The Clinical Quality Operations Manager will be accountable for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

The Clinical Quality Operations Manager is responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities. The Clinical Quality Operations Manager is responsible for maintaining appropriate levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide.

The Clinical Quality Operations Manager ensures that all actions and commitments related to audits and inspections are implemented in a timely manner. The Clinical Quality Operations Manager provides guidance and support for Clinical Quality Operations Managers regarding inspections at a country level sites that require a company headquarters input.

Education: B.A./B.S. or M.A./M.S. Degree or equivalent in 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.

Skills: Superior oral and written communication skills in an international environment. Ability to manage and develop others, including formal performance management when necessary. 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 our Research division. Able to act urgently for worldwide health authority inspection matters. Ability to analyze, interpret and solve complex problems. Ability to think strategically and objectively and with creativity and innovation. Ability to proficiently interact with all levels of specialists & management and exert influence to achieve results. Ability to identify and summarize the key issues from audits and inspections and to develop and deliver lessons learned.