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.

Operational Quality Management:

• The Clinical Quality Operations Manager is accountable for overseeing the strategic implementation of quality by design principles in assigned clinical trials.
• The Clinical Quality Operations Manager will develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the Clinical Trial Team.
• The Clinical Quality Operations Managers within a specific therapy area will collectively and periodically perform 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 and Head of Clinical Quality Operations as appropriate.
• The Clinical Quality Operations Manager will facilitate and oversee the responses to audit and inspection observations as appropriate. In addition, the Clinical Quality Operations Manager 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 partnership with the Clinical Quality Operations Lead, the Clinical Quality Operations Manager will develop skillsets 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 knowledge of Good Clinical Practice with respect to digital data management (i.e. use of novel technology within clinical trials).
• The Clinical Quality Operations Manager will 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 our research division QA and acting as the link between Clinical Development, study teams, global business functions and regional study management.
• The Clinical Quality Operations Manager, in partnership 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.
• The Clinical Quality Operations Manager is accountable for ensuring 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).

Inspection Preparation and Management:

• 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. Under the guidance of the Clinical Quality Operations Lead, 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.
• Work with other therapeutically aligned Clinical Quality Operations Managers 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 Clinical Quality Operations.
• Contributes to the development and/ or revision of Company policies, SOPs and training materials.
• Develops 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.
• Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, Clinical Quality Operations Team Country Operations, other Clinical Quality Operations Team functional areas, PV, GRACS, 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 Clinical Quality Operations, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and CAPAs, worldwide.
• Acts 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.
• Escalates potentially significant inspection findings/compliance risks/impact to Company Senior Management.
• Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.

CAPA Management Support:

• Ensures 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.
• Ensures 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 Quality Operations Managers regarding inspections at a country level sites that require a Company headquarters input.

Other activities:

• 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.
• Assesses and provides input to strengthen company programs/strategies (e.g. QCV, HQ QCP) with an aim to increase Inspection Readiness.
• 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 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.