The Medical Device Group Clinical R&D CoE (Center of Excellence), a member of Johnson & Johnson's Family of Companies, is recruiting for a World Wide – Quality Systems Leader, located in Irvine, Ca.
Under the supervision of the WW Clinical Quality Control and US Resource Management Director, this position is responsible for the following:
· Ensure clinical quality, process improvements and procedures (SOP) management and associated training management.
· Direct reports, contractors, and functional sources contracting, training, and performance.
· Develop Quality Control Plans and oversee/perform implementation of quality control activities for assigned projects according to agreed upon timelines.
· Conduct Quality Control activities which include, but are not limited to the following:
· Quality reviews of clinical trial protocols and associated documentation (including, but not limited to Patient Information Letters, Informed Consent Documents, Patient Questionnaires, CRFs, etc.), as appropriate, to ensure compliance with relevant standards/regulations.
· As applicable, review quality of Study Reports to confirm that the study was performed in accordance with the agreed upon protocol, regulatory requirements and that the clinical study is accurately and completely reported.
· Review of Trial Master File to ensure accuracy and completeness of the documentation.
· Independently perform and/or oversee the implementation of integrated and comprehensive data-driven QC activities to ensure compliance with regulatory requirements and SOPs and to ensure a continued state of inspection readiness.
· Take a lead role within Clinical R&D CoE in preparation, conduct and response to internal and external audits/inspections.
· Prepare periodic quality control reports for assigned clinical projects, identify areas of risk and review and communicate trends with Clinical Trial Core teams.
· Summarize Quality Control activities, trends and areas of potential risk to Clinical R&D Leadership.
· Maintain and update Clinical R&D SOPs, Work Instructions and Policy Documents to ensure they are in alignment with relevant standards/policies/regulations/directives.
· Using available systems tools (e.g., EDC, CTMS and eTMF generated dashboards and reports), compile monthly project performance metrics for department by organizing, analyzing, preparing presentation, and facilitating Clinical Management Review (CMR) meeting.
· Identify problems through analysis of project performance metrics and recommend corrective and preventive action (CAPA) based on knowledge of applicable regulations; ensure completion of CAPAs generated through internal and external audits.
· Support Clinical R&D CoE CAPA resolution by taking ownership, when applicable, on the corrective and preventative actions; track and ensure timely resolution of all Clinical R&D CAPAs.
· Actively engage and collaborate with Clinical Trial Managers/Leaders and other members of the Clinical R&D CoE, as applicable, to resolve any identified issues/problems.
· May visit sites with Monitors to improve site performance as necessary.
· Participate in FDA BIMO audit preparation and execution.
· Support the implementation of new clinical systems/processes.
· Responsible for managing training curriculum for all Clinical R&D COE associates, working with the relevant associates across the campus sites to ensure compliance with all training requirements
· May be involved in other tasks to support Clinical R&D Operations and Franchise, as needed.
· Participate in Clinical Trial/Study Core Team meetings, as required.
· Provide internal communication of important clinical data and events.
· Establish themselves as a reliable, trusted resource of accurate, up-to-date process knowledge as requested by key stakeholders.
· Collaborate with functional groups including, but not limited to BRQC and complaint handling groups to ensure Clinical R&D Operations adherence to company policies and regulations.
· Participate in departmental initiatives across the Clinical R&D CoE aimed at improving process and efficiency, in particular for the improvement of local processes.
· Responsible for ensuring personal and company compliance with all Federal, State, local, and company regulations, policies and procedures for Health, Safety, and Environmental compliance
· Participate in project management meetings and provide an overview of clinical quality and workload as needed.
· Bachelors or required.
· A minimum of 8 years of relevant experience is required.
· Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
· A minimum of 2 years supervisory experience is preferred.
· An understanding and application of GCP regulations and standards applied in clinical areas and medical devices/combination products is required
· Clinical/medical background is preferred
· A minimum of 2 years of Clinical Quality Control/Assurance experience
· Medical Device and Pharma and/or CRO monitoring experience is preferred
· Travel requirement is 20%, both domestic and internationally.
Depuy Orthopaedics. Inc. (6029)
Clinical Trial Administration
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