Ph3Job Function /h3 pQuality /p h3Job Sub Function /h3 pClinical Quality /p h3Job Category /h3 pProfessional /p h3Job Posting Locations /h3 ul liBeerse, Antwerp, Belgium, Breda, Netherlands, Leiden, Netherlands, Madrid, Spain /li /ul h3Job Description /h3 pJohnson Johnson is seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join our RD 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. /p h3Locations and Requisition Numbers /h3 ul liSpring House, PA; Titusville, NJ; Raritan, NJ – Requisition Number: R- /li liBeerse, Belgium; Basel, Madrid, Spain; Breda, the Netherlands; Leiden, the Netherlands – Requisition Number: R- /li liHigh Wycombe, UK – Requisition Number: R- /li liSwitzerland – Requisition Number: R- /li /ul h3Responsibilities /h3 ul liActively 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. /li liLead 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). /li liMaintain Clinical Quality Plans (CQP) in the quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations. /li liIndependently drive quality risk monitoring reviews and coach others on risk monitoring and mitigation reviews. /li liCommunicate and facilitate risk updates to RD colleagues as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned). /li liHighlight new potential systemic risks to RDQ CRM management. /li liDevelop and ensure a consistent interpretation of issues that require quality investigations. /li liProvide guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior RD management. /li liIn 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). /li liDrive 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. /li liProvide support for Investigator, Sponsor‑Monitor and third‑party inspections, including post‑inspection support. /li liProvide 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. /li /ul h3Qualifications /h3 ul liA minimum of a Bachelor's degree (scientific, medical, or related discipline) is required. /li liA minimum of 8 years working in the healthcare industry (pharmaceutical industry, contract research organization, and/or healthcare/hospital system) is required. /li liProven strong GCP Quality and/or clinical trials experience is required. /li liExcellent interpersonal, oral, and written communication skills to effectively collaborate in a cross‑functional team environment is required. /li liFlexibility to respond to changing business needs is required. /li liDemonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required. /li liProficiency in Microsoft Office Applications is required. /li liExperience with fundamentals of clinical trial risk management is preferred. /li liExperience working to ICH guidelines is preferred. /li liKnowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP) is preferred. /li liHealth Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred. /li liStrong Project Planning/Management skills is preferred. /li liExperience in managing escalations and CAPA support/advisement is preferred. /li liExperience 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. /li liExperience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred. /li liRequires proficiency in speaking and writing English. /li liUp to 10% of travel, primarily domestic with some international travel. /li /ul h3Benefits and Compensation /h3 pThe 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. /p h3Commitment to Diversity /h3 pWe 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. /p /p #J-18808-Ljbffr