Manager, Quality Clinical Risk Management

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Clinical Quality

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, 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

Job Description:

Johnson & Johnson is currently seeking a Manager, Quality Clinical Risk Management to join our R&D Quality CRM team located at a J&J office in Spring House, PA; Titusville, NJ; Raritan, NJ; Horsham, PA: High Wycombe, UK: Beerse, Belgium; Basel, Switzerland, and Madrid, Spain.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

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):

US- Requisition Number: R-106260

UK - Requisition Number: R-106893

Belgium - Requisition Number: R-106896

Spain- Requisition Number: R-106903

Switzerland - Requisition Number: R-106912

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

This is a position in R&D Clinical Quality. This Manager role is an independent clinical quality-risk leadership position responsible for translating risk signals into proactive mitigation, escalation, inspection/submission readiness, and quality decision support across trials and programs. The role combines hands-on risk ownership with significant cross-functional influence

With minimal direction from the RDQ Dir, Clinical Risk Management:

•Risk Management:

• Actively participates all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies.

• Leads regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound, as assigned).

• Maintains CQP (Clinical 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

• Communicates and facilitates 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).

• Highlight new potential systemic risk to RDQ CRM management.

Issue Consultation, Issue Escalation, and Compliance Assessment:

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

investigations

• Provides guidance for significant quality issues (SQI) per corporate standards and

escalates SQI to senior R&D management.

• Provides initial serious breach evaluation of quality issue that may require reporting

to Health Authorities

• In collaboration with partners in RDQ, provides advice on the development and

implementation of Corrective and Preventative Action (CAPA) Plans and

Effectiveness Checks (Self - Identified, Inspection, Audit)

Submission Support:

• Pre-submission Quality Portfolio Review (QPR)

• Leads the Cross-Functional Trial Team and other key contributors in QPR content

development & follow-up Activities

• Coaches and mentors other team members on QPR for coordination and

management of activities

Inspection Readiness and Support

• Drives ongoing inspection readiness activities with trial teams to develop inspection

narratives, identify and prepare sites of interest for inspection (including, preinspection

…