Clinical Quality Operations Manager (Remote)

Job Description

It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head of Clinical Quality Operations (HCQO), the Clinical Quality Operations Manager (CQOM)} is responsible for the execution of operational quality activities within the assigned therapeutic area. This includes 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 sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be responsible for the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach. The incumbent will be responsible for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

Primary Responsibilities:

Operational Quality Management

• Develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the Clinical Trial Team (CTT).

• Collectively and periodically (e.g. quarterly) perform a Therapeutic Area (TA) level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate.

• Responsible for ensuring comprehensive oversight of all activities delegated to third parties. This will include, but not be limited to: 1) Facilitating and monitoring CTT oversight of vendors; 2) Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies); and 3) Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizations (e.g. Non-Governmental Organization (NGO), government or academic institutions).

• Facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, the CQOM will work with peers to analyze data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies.

• In collaboration with the CQOL, the CQOM will develop skill sets in order to be able to recognize and appropriately respond to new and emerging risks through the use of technology. In particular this will include developing and maintaining a profound understanding of Good Clinical Practice (GCP) with respect to digital data management (i.e. use of novel technology within clinical trials).

• Build and enable effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness. This will include ongoing partnership with the Research & Development Division Quality Assurance (QA) and acting as the link between Clinical Development, study teams, global business functions and regional study management.

• In collaboration with peers, will contribute to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure consistency and seamless progression through the study lifecycle.

Inspection Preparation and Management

• Responsible for maintaining current regulatory inspection knowledge as it relates to GCP inspections by regulatory agencies worldwide, especially those conducted by key authorities such as the United States of America Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency, as well as other established and emerging authorities.

• Responsible for maintaining appropriate levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide. Under the guidance of the CQO Lead, the CQOM may be assigned as Point of Contact (POC) for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the CQOM is responsible for monitoring, interpreting and communicating key regulatory developments within CQO.

• Collaborate with other therapeutically aligned CQOM to provide comprehensive oversight of the TA. Maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.

• Develops, updates, and maintains GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO).

• Contributes to the development and/ or revision of our Company policies, SOPs and training materials.