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, management and follow up of regulatory inspections.

The Clinical Quality Operations Manager is responsible for:

• 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 in order to identify any emerging signals or trends and provide relevant feedback to the Clinical Quality Operations Lead.
• Facilitating and overseeing the responses to audit and inspection observations as appropriate.
• Developing skillsets in order to recognize and appropriately respond to new and emerging risks through the use of technology.
• Building and enabling effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness.
• Contributing to the standardization of Clinical Quality Operations procedures, tools and templates in order to ensure consistency and seamless progression through the study lifecycle.
• 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.
• Maintaining contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.
• Developing, updating, and maintaining GCP inspection procedures and guidelines within Clinical Quality Operations.
• Contributing to the development and/or revision of company policies, SOPs and training materials.
• Ensuring that a cross-functional team is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
• Maintaining and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and CAPAs, worldwide.
• Escalating potentially significant inspection findings/compliance risks/impact to company senior management.
• Developing the inspection management plan for each assigned and identified Regulatory Health Authority inspection.
• Ensuring that all actions and commitments related to audits and inspections are implemented in a timely manner.
• Providing guidance and support for Clinical Quality Operations Managers regarding inspections at a country level sites that require a company headquarters input.
• Providing input into GCP Quality and Compliance Council regarding the quality management system, RACT, Quality Plans and Regulatory Health Authority inspections status and results.
• Assessing and providing input to strengthen company programs/strategies with an aim to increase Inspection Readiness.
• Leading, driving, facilitating and/or supporting remediation, prevention activities as process improvement and training, as needed.

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.