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 CQOM 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 and enabling effective working relationships with key stakeholders.
• Contributing to the standardization of Clinical Quality Operations procedures, tools, and templates.
• Ensuring comprehensive oversight of all activities delegated to third parties.

The CQOM is responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide. The CQOM is responsible for maintaining appropriate levels of knowledge and skill to effectively lead and support GCP inspections, worldwide.

The CQOM is responsible for monitoring, interpreting, and communicating key regulatory developments within Clinical Quality Operations. The CQOM works with other therapeutically aligned CQOM to provide comprehensive oversight of the TA. The CQOM develops, updates, and maintains GCP inspection procedures and guidelines within Clinical Quality Operations.

The CQOM contributes to the development and/or revision of company policies, SOPs, and training materials. The CQOM develops the strategy for management and support for GCP inspections of company products to ensure that all phases of Regulatory Health Authority inspections are handled consistently, professionally, and proactively.

The CQOM ensures that a cross-functional team is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide. The CQOM acts 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 CQOM escalates potentially significant inspection findings/compliance risks/impact to company senior management. The CQOM develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.

The CQOM ensures that all actions and commitments related to audits and inspections are implemented in a timely manner. The CQOM tracks all inspection CAPA and regulatory commitments and checks evidence of completion. The CQOM ensures the repository of evidence in Documentum is complete for all Regulatory Health Authority inspections.

The CQOM provides guidance and support for CCQMs regarding inspections at a country level sites that require a company headquarters input.

The CQOM provides input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans, and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.

The CQOM assesses and provides input to strengthen company programs/strategies with an aim to increase Inspection Readiness.

The CQOM leads, drives, facilitates, and/or supports remediation, prevention activities as process improvement and training, as needed.

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.

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 the 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.

Salary range: $139,600.00 - $219,700.00