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.

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 in order to identify any emerging signals or trends.
• Facilitating and overseeing the responses to audit and inspection observations.
• 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.
• Contributing to the standardization of Clinical Quality Operations procedures, tools and templates.
• Ensuring comprehensive oversight of all activities delegated to third parties.

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 may be assigned as Point of Contact for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the Clinical Quality Operations Manager is responsible for monitoring, interpreting and communicating key regulatory developments within Clinical Quality Operations.

The Clinical Quality Operations Manager will work with other therapeutically aligned Clinical Quality Operations Managers to provide comprehensive oversight of the TA. The Clinical Quality Operations Manager will maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity.

The Clinical Quality Operations Manager will develop, update, and maintain GCP inspection procedures and guidelines within Clinical Quality Operations. The Clinical Quality Operations Manager will contribute to the development and/or revision of Company policies, SOPs and training materials.

The Clinical Quality Operations Manager will develop the strategy for management/support for GCP inspections of Company products to ensure that all phases of Regulatory Health Authority inspections (i.e. inspection preparation, management and follow up) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company's dedication to regulatory compliance.

The Clinical Quality Operations Manager will ensure that a cross-functional team is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide. The Clinical Quality Operations Manager will maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and CAPAs, worldwide.

The Clinical Quality Operations Manager will act as the subject matter expert and primary point of contact for relevant functional areas on Inspection Management in order to provide real-time, proactive advice and guidance. The Clinical Quality Operations Manager will escalate potentially significant inspection findings/compliance risks/impact to Company Senior Management.

The Clinical Quality Operations Manager will develop the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.

The Clinical Quality Operations Manager will ensure that all actions and commitments related to audits and inspections are implemented in a timely manner. The Clinical Quality Operations Manager will track all inspection CAPA and regulatory commitments and check evidence of completion.

The Clinical Quality Operations Manager will provide guidance and support for Clinical Quality Operations Managers regarding inspections at a country level sites that require a Company headquarters input.

The Clinical Quality Operations Manager will provide 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 Clinical Quality Operations Manager will assess and provide input to strengthen company programs/strategies with an aim to increase Inspection Readiness.

The Clinical Quality Operations Manager will lead, drive, facilitate and/or support 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.

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.