{"id":3206483,"url":"https://alion.io/job/johnson-johnson-manager-quality-clinical-risk-management-2","title":"Manager, Quality Clinical Risk Management","company":{"id":14152,"name":"Johnson & Johnson","domain":"jnj.com","url":"https://alion.io/company/jnj","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":88,"open_postings":205,"ghost_share":0,"stale_share":0.688,"repost_share":0,"time_to_fill_p50_days":10,"computed_at":"2026-11-04T06:34:25Z"}},"role":"Finance","role_family":"Finance","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Beerse, Belgium"],"countries":["BE"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":79800,"max":137770,"currency":"EUR","period":"year","gross":null,"usd_annual":154353},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GCP","optional":false},{"name":"GLP","optional":false},{"name":"GMP","optional":false},{"name":"Matter","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Tableau","optional":false}],"status":"live","first_seen_at":"2026-10-23T00:00:00Z","employer_posted_date":"2026-10-23","last_verified_at":"2026-11-05T01:24:17Z","board_verified":true,"closed_at":null,"days_open":13,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":13},"description":"At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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.\nAs 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.\nJob Function:\nQualityJob Sub Function:\nClinical QualityJob Category:\nProfessionalAll Job Posting Locations:\nBeerse, Antwerp, BelgiumJob Description:\nJohnson & 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.\nAbout Innovative Medicine\nOur 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.\nJoin us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.\nLearn more at https://www.jnj.com/innovative-medicine\nPlease 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):\nUS- Requisition Number: R-106260\nUK - Requisition Number: R-106893\nBelgium - Requisition Number: R-106896\nSpain- Requisition Number: R-106903\nSwitzerland - Requisition Number: R-106912\nRemember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.\nThis 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\nWith minimal direction from the RDQ Dir, Clinical Risk Management:\n\nRisk Management:\nActively 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.\nLeads 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).\nMaintains CQP (Clinical Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews\nIndependently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews\nCommunicates 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).\nHighlight new potential systemic risk to RDQ CRM management.\nIssue Consultation, Issue Escalation, and Compliance Assessment:\nDevelops and ensures a consistent interpretation of issues that require quality\ninvestigations\nProvides guidance for significant quality issues (SQI) per corporate standards and\nescalates SQI to senior R&D management.\nProvides initial serious breach evaluation of quality issue that may require reporting\nto Health Authorities\nIn collaboration with partners in RDQ, provides advice on the development and\nimplementation of Corrective and Preventative Action (CAPA) Plans and\nEffectiveness Checks (Self - Identified, Inspection, Audit)\nSubmission Support:\nPre-submission Quality Portfolio Review (QPR)\nLeads the Cross-Functional Trial Team and other key contributors in QPR content\ndevelopment & follow-up Activities\nCoaches and mentors other team members on QPR for coordination and\nmanagement of activities\nInspection Readiness and Support\nDrives ongoing inspection readiness activities with trial teams to develop inspection\nnarratives, identify and prepare sites of interest for inspection (including, preinspection\nvisit support), ensure availability of key documents/records and\ncoordinates mock inspection in collaboration with Regulatory Compliance teams.\nProvides front and back room support for Sponsor-Monitor inspections at J&J Sites\nincluding post inspection support. Provide inspection support per contractual\nagreement for third party inspections (vendors, co-development partners and\ncontract research organizations)\nProvides remote support for investigational site inspections including post\ninspection support.\nProvides supervision and/or coaching for others on inspection support and\nreadiness\nConsultancy\nProvides independent advice on questions related to research quality and\ncompliance from Business Partners in collaboration with other Quality Professionals\nand Subject Matter Experts to ensure consistent interpretation of international\nregulations and policy.\nPost-licensing and Acquisition (L&A) / Integration:\nWith the guidance from the CRM L&A Team and Therapeutic Area Head or Delegate:\nSupport the coordination of the quality integration of the acquiring asset or\ncompany/partner and deliver robust documentation within the program/trial\nintegration plans (90-day plan) and execute assigned responsibilities per plan.\nProvide general guidance to stakeholders\nAs required, provide input into Quality Agreements with (Co-)development Partners\nand execute responsibilities per agreement.\nSupports and facilitates asset divestment\nOther activities:\nParticipates 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).\nWorks with limited supervision, independently making decisions for compounds and studies\nProvides training and coaching to peers and new employees, as needed\nRequired Minimum Education: BA/BSc or equivalent (Scientific, medical, or related discipline)\nRequired 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\nRequired Knowledge, Skills and Abilities:\nProficiency in Microsoft Office Applications\nProficiency in speaking and writing English\nExcellent interpersonal, oral, and written communication skills\nProven strong GCP quality and/or clinical trials experience\nExperience collaborating in a cross-functional team environment\nFlexibility to respond to changing business needs\nDemonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures\nPercentage Traveled:\nUp to 10% (Primarily domestic travel with some international travel)\nPreferred Related Industry Experience: Healthcare industry (pharmaceutical industry and/or\nhealthcare/hospital system)\nPreferred Knowledge, Skills and Abilities:\nKnowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP)\nExperience with fundamentals of clinical trial risk management\nGlobal clinical trial experience\nExperience working in a Quality function (Quality Management, Quality Assurance/Control and / or Compliance)\nExperience working to ICH guidelines\nHealth Authority Inspection experience (FDA, EMA and other inspectorates)\nStrong Project Planning/Management skills\nExperience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related)\nProven ability to analyze & interpret collective data to provide insights to drive decision-making\nExperience in managing escalations and CAPA support/advisement\nExperience with Data Science and Digital Health (including Real World Evidence/Real World Disease)\nJohnson & 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.\nJohnson & 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.\nRequired Skills:\nPreferred Skills:\nThe anticipated base pay range for this position is:\n€79,800.00 - €137,770.00Benefits:\nIn addition to base pay, we offer the following 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.\n*This is for informative purposes only. 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