Clinical Quality Operations, Oncology III

Job description

Job Description Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. Overarching Tasks: It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL and Head of CQO, the CQOM 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, 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 CQOM will develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT. · The CQOMs within a specific therapy area will collectively and periodically (e.g. quarterly) 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 CQOL and Head of CQO as appropriate.· · The CQOM will 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. · In partnership with the CQOL, the CQOM 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 CQOM 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 CQOM is accountable for ensuring comprehensive oversight of all activities delegated to third parties. Inspection Preparation and Management: The CQOM 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. Under the guidance of the CQO Lead, the CQOM may be assigned as Point of Contact for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.). As such, the CQOM is responsible for monitoring, interpreting and communicating key regulatory developments within CQO. · Work 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. · Ensures that a cross-functional team (e.g. Quality & Continuous Improvement (QCI) colleagues, GCTO Country Operations, other GCTO 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 CQO, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and CAPAs, worldwide. · 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 (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 CCQMs regarding inspections at a country level sites that require a Company headquarters input. Other activities: · Provides input into GCP Quality and Compliance Council. · Assesses and provides input to strengthen company programs/strategies (e.g. QCV, ) 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. · 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, critically, and objectively with creativity and innovation. Required Skills: Adaptability, Clinical Quality Management, Clinical Study Design, Clinical Trials Monitoring, Data Analysis, Emerging Risks, Good Clinical Practice (GCP), Process Improvement Projects, Regulatory Compliance, Regulatory Inspections, Risk Management, Stakeholder Relationship Management, Strategic Thinking, Training and Development Preferred Skills: Oncology Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected charac