Manager, Quality Clinical Risk Management

Johnson & Johnson Co.; Geel; On-site; EUR 80,000 - 138,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson is seeking a Manager, Quality Clinical Risk Management to join our R&D Quality CRM team. The role leads risk identification, mitigation and escalation across trials with cross-functional influence, at multiple global sites including Beerse, Belgium.

You will translate risk signals into proactive mitigation, CAPA plans, and readiness activities, requiring strong GCP knowledge and extensive clinical trials experience.

Qualifications

• Proficiency in Microsoft Office Applications.
• Proficiency in speaking and writing English.
• Excellent interpersonal, oral, and written communication skills.
• GCP quality and/or clinical trials experience.
• Experience collaborating in a cross-functional team environment.
• Flexibility to respond to changing business needs.
• Ability to operate across diverse regional and global business structures.

Responsibilities

• Actively participates in risk identification and mitigation for trials.
• Lead regular reviews of risk areas with Risk Owners.
• Maintain Clinical Quality Plans risk monitoring information.
• Drive quality risk monitoring reviews and coach others.
• Communicate risk updates to RDQ CRM management and partners.
• Provide guidance on CAPA plans and effectiveness checks.

Education

BA/BSc or equivalent (Scientific, medical, or related discipline)

8 years in healthcare industry

Job description

Job Function:

Quality

Job Sub Function:

Clinical Quality

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium

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. 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)

Salary:

The anticipated base pay range for this position is: €79,800.00 - €137,770.00

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 https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Benefits:

• an annual bonus with set target (% of pay) depending on pay grade / location, where the actual 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.
• *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

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 https://www.jnj.com/.

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