Job Function
Quality
Job Sub Function
Clinical Quality
Job Category
Professional
Job Posting Locations
* Beerse, Antwerp, Belgium, Breda, Netherlands, Leiden, Netherlands, Madrid, Spain
Job Description
Johnson & Johnson is seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join our R&D Quality CRM team located in multiple offices worldwide, including Spring House, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium; Basel, Switzerland; High Wycombe, UK; Madrid, Spain; Breda, the Netherlands; and Leiden, the Netherlands.
Locations and Requisition Numbers
* Spring House, PA; Titusville, NJ; Raritan, NJ – Requisition Number: R-071027
* Beerse, Belgium; Basel, Madrid, Spain; Breda, the Netherlands; Leiden, the Netherlands – Requisition Number: R-070406
* High Wycombe, UK – Requisition Number: R-071134
* Switzerland – Requisition Number: R-071137
Responsibilities
* Actively participate 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.
* Lead regular review of risk areas in collaboration with Risk Owners to evaluate progress of risk mitigations and risk reduction, and identify potential new risks or additional mitigation needs (trial and/or compound, as assigned).
* Maintain Clinical Quality Plans (CQP) in the quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations.
* Independently drive quality risk monitoring reviews and coach others on risk monitoring and mitigation reviews.
* Communicate and facilitate 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 risks to RDQ CRM management.
* Develop and ensure a consistent interpretation of issues that require quality investigations.
* Provide guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management.
* In collaboration with partners in RDQ, provide advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self‑Identified, Inspection, Audit).
* Drive 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 coordinate mock inspection in collaboration with Regulatory Compliance teams.
* Provide support for Investigator, Sponsor‑Monitor and third‑party inspections, including post‑inspection support.
* Provide 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.
Qualifications
* 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 organization, and/or healthcare/hospital system) is required.
* Proven strong GCP Quality and/or clinical trials experience is required.
* Excellent interpersonal, oral, and written communication skills to effectively collaborate in a cross‑functional team environment is required.
* Flexibility to respond to changing business needs is required.
* Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required.
* Proficiency in Microsoft Office Applications is required.
* Experience with fundamentals of clinical trial risk management is preferred.
* Experience working to ICH guidelines is preferred.
* Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP) is preferred.
* Health Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred.
* Strong Project Planning/Management skills is preferred.
* Experience in managing escalations and CAPA support/advisement is preferred.
* Experience and/or proficiency with data analytics and/or data visualization tools (e.g., Tableau, Spotfire, or related) to analyze/interpret collective data and provide insights to drive decision‑making is preferred.
* Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred.
* Requires proficiency in speaking and writing English.
* Up to 10% of travel, primarily domestic with some international travel.
Benefits and Compensation
The anticipated base pay range for this position in the Netherlands is €79,800.00 to €137,770.00 on an annual basis and includes 8% holiday allowance, plus attractive benefits.
Commitment to Diversity
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.
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