Sr. Manager, Clinical Quality Risk Management Lead

Job Function

Quality

Clinical Quality

Professional

Cincinnati, Ohio, United States of America, Irvine, California, United States of America, Jacksonville, Florida, United States of America, Miami, Florida, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, Santa Clara, California, United States of America

Johnson & Johnson is recruiting for a Sr. Manager, Clinical Quality Risk Management Lead at a Med Tech site in one of the following locations:
Raritan, NJ;
New Brunswick, NJ;
Jacksonville, FL;
Miami, FL;
Cincinnati, OH;
Raynham, MA;
Santa Clara, CA or Irvine, CA.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

The Sr. Manager, Clinical Quality Risk Management Lead for Surgery advances the Clinical Quality Risk Management (CQRM) objective, overseeing a robust GxP Quality Management System to enable a diverse portfolio of medical device health products and services within the Surgery Business. This individual serves as a subject matter expert, providing guidance on compliance-related activities across the business units in Good Clinical Practices (GCP) and/or Good Documentation Practices (GDP).

The Sr. Manager, Clinical Quality Risk Management Lead is a trusted advisor to the Business Unit Quality Head and Research & Development (R&D) functions, overseeing the establishment and execution of a Quality Management System (QMS) to ensure compliance of Bioresearch with applicable regulatory requirements, enterprise standards, and company policies and procedures.

The Sr. Manager, Clinical Quality Risk Management Lead oversees the overall clinical quality risk management of the Surgery Med Tech Business. They work across teams to ensure the coordination of the identification, assessment, and mitigation of clinical quality risks that could have an impact on trial data integrity, patient rights, safety, or well‑being.

Throughout the duration of the clinical program, the Sr. Manager, Clinical Quality Risk Management Lead, oversees 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.

• Ensures CQRM representatives are invited to actively participate in pre‑study activities, contributing to the identification and assessment of key risks in the clinical protocol/set‑up and advising clinical/cross functional trial team members on effective mitigation strategies.
• Ensures a consistent clinical quality risk assessment process across the program.
• Provides and leads strategic guidance to CQRM representatives on quality risk assessments, risk entries, and mitigation strategies. If assigned, approves IQP (Integrated Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews.
• Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews.
• Ensures a strategic communication framework with business partners and quality management governance to keep them informed on key quality risks and mitigations.
• Communicates and facilitates risk updates to Business Unit Business Partners as part of the regular review cycle through Clinical Management Reviews, Quality System Management Reviews, Quality Working Groups and Governance Fora, as applicable.
• Works with risk owners to develop effective risk mitigation plans to control risks in the trial level IQP.
• Highlights new potential systemic risks to R&D Quality management.

• Develops and ensures a consistent interpretation of issues that require quality…