Title Manager, Clinical Risk Management

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld 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 Med Tech, 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  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:
Madrid, Spain

Johnson & Johnson is currently seeking a Manager, Cross Therapeutic Area 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;
Beerse, Belgium; and Basel, Switzerland.

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

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-074849 Belgium

- Requisition Number: R-076146 Switzerland
- Requisition Number: R-076148 Spain- R-077313 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job description to follow:

• Actively participates in 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) in quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews
• Communicates and facilitates risk updates to R&D colleagues 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.
• 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.
• 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)
• Drives ongoing inspection readiness activities with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.
• Provides support for Investigator, Sponsor-Monitor and third-party inspections including post inspection support
• Provides independent advice on questions related to research quality and compliance from clinical teams in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.

• A minimum of a Bachelor’s degree (scientific, medical, or related discipline) is required.
• A minimum of 8 years working in the healthcare industry (pharmaceutical industry, contract research…