SKILLS AND EDUCATION:

• Bachelor’s/ Master’s Degree or equivalent in relevant health care area. Further formal education in quality management or business management is desirable.
• Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.
• Profound knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required.
• Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
• Experience with delivering effective CAPA management solutions.
• Experience with risk management tools and processes within the clinical quality framework.
• Superior oral and written communication skills in an international environment.
• Ability to manage and develop others, including formal performance management when required.
• 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 Client
• 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.

POSITION PURPOSE:

The Clinical Quality Operations Manager (CQOM), in collaboration with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality Operations (CQO), 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 Client sponsored trials, ensure adequate vendor oversight and address any quality issues as needed.
The CQOM will be responsible for the development of Quality Plans to implement Quality by Design within clinical Development Programs, using a risk-based approach.
The CQOM 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 DUTIES:

Operational Quality Management:

• Develop Risk Assessment and Categorization Tools (RACT) 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 within a specific therapy area.
• Ensure comprehensive oversight of all activities delegated to third parties.This will include, but not be limited to:
• Facilitating and monitoring CTT oversight of vendors
• Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies).
• Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial organizations (e.g. 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.
• Develop skillsets, in collaboration with the CQOL, 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 Client QA and acting as the link between Clinical Development, study teams, global business functions and regional study management.
• 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:

• Maintain 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.
• Maintain 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 Clinical Operations Manager (COM) 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.
• Develop, update, and maintain GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO).
• Contributes to the development and/ or revision of Client policies, SOPs and training materials.
• Develops the strategy for management/support for GCP inspections of Client 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 commitment to regulatory compliance.
• Ensure that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs (GRA), IT, etc.) is fully informed and prepared to support any Regulatory Health Authority inspection, worldwide.
• In collaboration with the Global Inspection Coordinator and Head of CQO, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and Corrective and Preventive Actions (CAPAs) worldwide.
• 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.
• Escalate potentially significant inspection findings/compliance risks/impact to Client Senior Management.
• Develop the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.

CAPA Management Support:

• Ensure that all actions and commitments related to audits and inspections are implemented in a timely manner. Tracks all inspection CAPA and regulatory commitments and checks evidence of completion.
• Ensure repository of evidence in Documentum (containing evidence of CAPA and commitment completion, as well as other definitive inspection documentation) is complete for all Regulatory Health Authority inspections. Provides guidance and support for Clinical Country Quality Managers (CCQMs) regarding inspections at a country level sites that require a Client headquarters input.