Director, Cross TA Clinical Risk Mgmt

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Quality

Clinical Quality

People Leader

Horsham, Pennsylvania, United States of America, Miami, Florida, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

We are searching for the best talent for Director, Cross TA Clinical Risk Management to join our Quality Assurance and Compliance organization located in Raritan, NJ;
Titusville, NJ;
Horsham, PA;
Spring House, PA; or Miami, FL. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Allschwil, Switzerland;
Beerse, Belgium;
High Wycombe, UK - Requisition Number: R-061312. Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. The Director, Cross TA Clinical Risk Management, reports to the Head of Clinical Risk Management and is primarily responsible to oversee the overall risk management of the Cross TA Delivery Unit for Neuroscience, Cardiopulmonary and Communicable Disease late development trials.

They work with the CRM Representatives to ensure the coordination of the identification, assessment, and mitigation of quality risks that could have an impact on trial data integrity, patient rights, safety, or well‑being.

• Oversee the execution of data-driven, risk-based trial and program oversight activities that deliver quality in the execution of clinical trial programs, compliance with regulatory requirements and internal procedures, and that there is a continued state of inspection readiness;
• Manage a team of CRM representatives that will provide consistent quality oversight to clinical trials in the Cross TA portfolio;
• Provide and lead strategic guidance to CRM representatives on quality risk assessments, risk entries, and mitigation strategies. Approve CQP (Clinical Quality Plans) risk monitoring information in the quality risk repository to facilitate regular progress reviews;
• Independently drive quality risk monitoring reviews and coach others on risk monitoring and mitigation reviews;
• Ensure a strategic communication framework with business partners and quality management governance to keep them informed on key quality risks and mitigations;
• Communicate and facilitate risk updates to R&D Business Partners as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned);
• Develop and ensure a consistent interpretation of issues that require quality investigations;
• Provide guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management;
• In collaboration with partners in RDQ, provide advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self‑Identified, Inspection, Audit);
• Independently lead key inspection processes and inspection tools to maintain an ongoing inspection readiness with trial teams to develop…