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, andsolutions 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.Job Function: Quality Job Sub Function: Clinical Quality Job Category: 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; About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science?Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. 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 programmes. 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?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
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.
Identified, Inspection, Audit).
Submission Support: Pre?submission Quality Portfolio Review (QPR)




Functional Trial Team and other key contributors in QPR content development & follow?Coaches and mentors other team members on QPR for coordination and management of activities.
Inspection Readiness and Support
inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.
Provides front and back room support for Sponsor?Monitor inspections at J&J; Sites including post inspection support.
Provide inspection support per contractual agreement for third?party inspections (vendors, co?development partners and contract research organizations).
Provides remote support for investigational site inspections including post inspection support.
Provides supervision and/or coaching for others on inspection support and readiness.
Consultancy
Provides independent advice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.
Post?licensing and Acquisition (L&A;) / Integration
Support the coordination of the quality integration of the acquiring asset or company/partner and deliver robust documentation within the program/trial integration plans (90?Provide general guidance to stakeholders.
As required, provide input into Quality Agreements with (Co?)Supports and facilitates asset divestment.
Participates in CRM, cross?sector working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions (as a team member or workstream/project lead).
Works with limited supervision, independently making decisions for compounds and studies.
Provides training and coaching to peers and new employees, as needed.
A minimum of 8 years of experience working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) required
Proficiency in Microsoft Office Applications
Proficiency in speaking and writing English
Proven strong GCP quality and/or clinical trials experience
Flexibility to respond to changing business needs




Demonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures
Healthcare industry (pharmaceutical industry and/or healthcare/hospital system)
Experience with fundamentals of clinical trial risk management
Global clinical trial experience
Experience working in a Quality function (Quality Management, Quality Assurance/Control and / or Compliance)
Health Authority Inspection experience (FDA, EMA and other inspectorates)
Strong Project Planning/Management skills
Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related)
Proven ability to analyze & interpret collective data to provide insights to drive decision?Experience in managing escalations and CAPA support/advisement
Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease)
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.
We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
LI-Hybrid
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the vigente amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions.
Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well?being reimbursement, programs for financial, physical and mental health.
We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location's eligible dependents - can participate in several insurance plans.
For more information, visit Employee benefits | Supporting well?being & career growth | Johnson & Johnson Careers.
*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, andsolutions 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.

📌 Manager, Quality Clinical Risk Management (Madrid)
🏢 Johnson & Johnson
📍 Madrid