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.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:**
High Wycombe, Buckinghamshire, United Kingdom
**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 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-
UK - Requisition Number: R-
Belgium - Requisition Number: R-
Spain- Requisition Number: R-
Switzerland - Requisition Number: R-
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
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:
With the guidance from the CRM L&A Team and Therapeutic Area Head or Delegate:
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-day plan) and execute assigned responsibilities per plan.
Provide general guidance to stakeholders
As required, provide input into Quality Agreements with (Co-)development Partners
and execute responsibilities per agreement.
Supports and facilitates asset divestment
Other activities:
Participates in CRM, cross-RDQ J&J, cross-functional, or 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
Required Minimum Education: BA/BSc or equivalent (Scientific, medical, or related discipline)
Required Years of Related Experience: A minimum of 8 years of experience working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) required
Required Knowledge, Skills and Abilities:
Proficiency in Microsoft Office Applications
Proficiency in speaking and writing English
Excellent interpersonal, oral, and written communication skills
Proven strong GCP quality and/or clinical trials experience
Experience collaborating in a cross-functional team environment
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
Percentage Traveled:
Up to 10% (Primarily domestic travel with some international travel)
Preferred Related Industry Experience: Healthcare industry (pharmaceutical industry and/or
healthcare/hospital system)
Preferred Knowledge, Skills and Abilities:
Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP)
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)
Experience working to ICH guidelines
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-making
Experience in managing escalations and CAPA support/advisement
Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease)
Johnson & Johnson is an Equal Opportunity Employer. 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.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
**Required Skills:**
**Preferred Skills:**
Manager,Quality Clinical Risk Management in High Wycombe employer: J&J Family of Companies
At Johnson & Johnson, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work environment that fosters personal and professional growth. Our commitment to diversity, equity, and inclusion ensures that every employee feels valued and empowered to reach their full potential, while our comprehensive benefits package supports both physical and mental wellbeing. Located in North London and Hertfordshire, you will be part of a pioneering team at the forefront of healthcare innovation, making a meaningful impact on lives around the world.
