Manager, Serious Breach Office

Job Function: Quality

Job Sub Function: Clinical Quality

Job Category: Professional

All Job Posting Locations: Beerse, Antwerp, Belgium; High Wycombe, Buckinghamshire, United Kingdom; Issy-les-Moulineaux, France

Position Summary: The Serious Breach Office (SBO), Manager is a member of the Clinical Risk Management-Operational Excellence (CRM-OpEx) function of R&D Quality (RDQ). This role provides JJIM awareness, facilitation and alignment of the processes that enable compliance to the country and regional level serious breach reporting requirements for JJIM sponsored clinical trials. The incumbent will drive accountability in the implementation of the RDQ serious breach reporting process under the guidance of the SBO management and in collaboration with contributing business partners. Through the coordination and consultation of stakeholder business partners, the SBO Manager will facilitate the assessment of significant quality issues related to JJIM sponsored clinical trials for reportability to serious breach reporting countries and/or regions.

Main Responsibilities:

• Serious Breach Office (SBO): As a facilitator of the serious breach process and record owner, you will drive the assessments and reporting of issues or events related to JJIM clinical trials that meet the serious breach reporting criteria to the appropriate corresponding Health Authorities. You will be a member of a team designated as the primary subject matter experts for the JJIM organization to ensure compliance, effectiveness, and continual improvement of the serious breach reporting and detection processes.
• Serious Breach Process Facilitator: As a designated SBO Lead, you will define, drive and enhance oversight strategies and monitoring capabilities to ensure the effectiveness and compliance elements of the serious breach process within clinical trial risk and issue management framework. You will facilitate early consultation and timely assessment activities across stakeholder organizations and varying levels of JJIM leadership to ensure the appropriate dispositioning of potential serious breaches related to JJIM clinical trials.
• Process Performance Monitoring: You will develop, assess and report performance metrics related to quality, efficiency, and risk for serious breach process execution and timely case reporting identifying process and/or compliance strengths and gaps for management review.
• Continual Improvement Driver: As a steward of continual process improvement, you will monitor adherence to implemented process controls, effectiveness and risk management requirements in alignment with associated business partner processes, enterprise standards and industry regulations to develop proposals for optimization initiatives. You will identify and deliver key improvements to the serious breach process in collaboration with CRM, and key business partners-RDQA, GD, Legal, JJIMQ, and GRA.
• Data Analysis and Visualization: As a presenter and primary monitor of serious breach reporting process effectiveness, you will collaborate with stakeholders to create and monitor meaningful digital dashboards that enable clear interpretation and data-driven decision making.
• Leadership in Serious Breach Meetings: As a representative of the Serious Breach Office during process, strategic, and/or data reviews, you will model the appropriate level of preparedness, executive presence, confidence and assertiveness to thoroughly enable efficient, data-driven decisions and actions.
• Collaboration with Serious Breach Process Stakeholders: As part of the RDQ and broader J&J community, you will partner with RDQ QANA, R&D stakeholders and other potential sources of benefit from across IM and MedTech to develop templates, scorecards, and dashboards that simplify activities for functional teams and contributors.
• X-Functional Strategic Support: As a Leader within the CRM-OpEx team, you will represent your function in support of core RDQ and business partner initiatives.

Additional responsibilities include vigilant continuing education and research into the regulatory landscape of serious breach reporting, competitor process benchmarking, external reporting analysis, and JJIM serious breach training platforms. You should have the ability to interpret problems, create proposals, and implement solutions that effectively address gaps and/or areas of potential improvements. Manage projects with a high level of independence to ensure timely and accurate completion of activities. Strong communication skills with a confirmed ability to effectively engage and balance key internal cross-functional internal and external business partners (including Health Authorities) are essential. Strong collaboration, alignment, and influencing skills with the ability to summarise and present results are also required.

Qualifications:

Education: Bachelor's degree is required in a scientific, medical or related discipline.

Skills & Capabilities: A minimum of 1-3 years of relevant experience working in the health care industry required; pharmaceutical, medical device, Biologics company and/or Health Authority experience is required. Experience in clinical trial execution at a sponsor, investigational site or CRO, clinical trial document management, and/or GCP compliance functions preferred. Strong organizational and project management skills are required. Strong meeting facilitation skills are required. Experience leading and influencing complex, cross-functional teams is required. Previous experience with fundamentals of clinical trial risk management, serious breach reporting requirements, and corresponding ICH guidelines is required. Proficiency with data visualization tools (i.e., Tableau, Spotfire, or related) preferred. Ability to collect, analyse, interpret and present collective data to enable data-driven decision making is required. A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills required. Proficient in Microsoft Office Applications required. Travel ~10%-15% primarily domestic and/or international required.