PpAt 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. 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. /ph3Role Overview /h3pThe Director, Clinical Risk Management Post Approval Delivery Unit oversees the overall risk management of a Disease Area Stronghold (DAS) or development phase. Works with CRM Representatives to ensure the coordination of, identification, assessment, and mitigation of quality risks that could have an impact on trial data integrity, patient rights, safety, or well‐being. You also provide oversight to the execution of data‐driven, risk‐based trial and program oversight activities that deliver quality in the execution of clinical trial programs, compliance with regulatory requirements and internal procedures, and that there is a continued state of inspection readiness. /ph3People Leader Responsibilities /h3ulliEstablishes goals and objectives for CRM Representatives. /liliPerforms mid‑year and end‑of‑year review for CRM Representatives. /liliAssists in outlining and evaluating career development goals with CRM Representatives. /liliWorks with team members to establish workstreams to update processes for efficiency and maintaining inspection readiness. /liliCoordinates upskilling knowledge workshop series for CRM Representative team development. /li /ulh3Risk Management /h3ulliEnsures CRM representatives are invited to actively participate in pre‑study activities, contributing to the identification and assessment of key risks in the clinical protocol/set‑up and advising clinical/cross‑functional trial team members on effective mitigation strategies. /liliEnsures a consistent quality risk assessment process across the program. /liliProvides and leads strategic guidance to CRM representatives on quality risk assessments, risk entries, and mitigation strategies. /liliIf assigned, approves CQP (Clinical Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews. /liliIndependently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews. /liliEnsures a strategic communication framework with business partners and quality management governance to keep them informed on key quality risks and mitigations. /liliCommunicates and facilitates risk updates to RD Business Partners as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable. /liliWorks with risk owners to develop effective risk mitigation plans to control risks in the trial level CQP Highlight new potential systemic risks to RDQ / CRM management. /li /ulh3Issue Consultation, Issue Escalation, and Compliance Assessment /h3ulliIn consultation with the Head of Clinical Risk Management: Develops and ensures a consistent interpretation of issues that require quality investigations. /liliProvides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior RD management. /liliProvides 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). /li /ulh3Inspection Readiness and Support /h3ulliIndependently leads key inspection processes and inspection tools to maintain an ongoing inspection readiness 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 coordinates mock inspection in collaboration with Regulatory Compliance teams. /liliProvides front and back room support for Sponsor‑Monitor inspections at JJ Sites including post inspection support. /liliProvides inspection support per contractual agreement for third‑party inspections (vendors, co‑development partners and contract research organizations). /liliProvides remote support for investigational site inspections including post inspection support. /liliProvides mentorship and/or coaching for others on inspection support and readiness. /li /ulh3Consultancy /h3ulliProvides 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. /li /ulh3Post‑Licensing and Acquisition (LA)/Integration /h3ulliWith guidance from the RDQ LA Team and Therapeutic Head or Delegate: Supports and leads the coordination of the quality integration of the acquiring asset or company/partner and delivers robust documentation within the program/trial integration plans (90‑day plan) and execute assigned responsibilities per plan. /liliProvides and leads general guidance to stakeholders. /liliAs required, provides, and leads input into Quality Agreements with (Co)‑development Partners and executes responsibilities per agreement. /liliSupports and facilitates asset divestment. /li /ulh3Qualifications Requirements /h3ulliA minimum of a Bachelor’s degree (scientific, medical, or related discipline) is required. /liliA minimum of 10 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required. /liliProven strong GCP Quality and/or clinical trials experience is required. /liliExcellent interpersonal, oral, and written communication skills to effectively collaborate in a cross‑functional team environment is required. /liliFlexibility to respond to changing business needs is required. /liliDemonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required. /liliProficiency in Microsoft Office Applications is required. /liliExperience with fundamentals of clinical trial risk management is preferred. /liliExperience working to ICH guidelines is preferred. /liliKnowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP) is preferred. /liliHealth Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred. /liliStrong Project Planning/Management skills is preferred. /liliExperience in managing escalations and CAPA support/advisement is preferred. /liliExperience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related) to analyze/interpret collective data and provide insights to drive decision‑making is preferred. /liliExperience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred. /liliRequires proficiency in speaking and writing English. /liliUp to 10% of travel, primarily domestic with some international travel. /li /ulh3Required Skills /h3ulliBudget Management /liliClinical Research and Regulations /liliClinical Trials Operations /liliCompliance Management /liliCompliance Risk /liliContinuous Improvement /liliDeveloping Others /liliFact‑Based Decision Making /liliInclusive Leadership /liliLeadership /liliOperations Management /liliPerformance Measurement /liliQuality Control (QC) /liliQuality Management Systems (QMS) /liliQuality Standards /liliRisk Assessments /liliStandard Operating Procedure (SOP) /liliTactical Planning /liliVendor Selection /li /ulh3Preferred Skills /h3ulliBudget Management /liliClinical Research and Regulations /liliClinical Trials Operations /liliCompliance Management /liliCompliance Risk /liliContinuous Improvement /liliDeveloping Others /liliFact‑Based Decision Making /liliInclusive Leadership /liliLeadership /liliOperations Management /liliPerformance Measurement /liliQuality Control (QC) /liliQuality Management Systems (QMS) /liliQuality Standards /liliRisk Assessments /liliStandard Operating Procedure (SOP) /liliTactical Planning /liliVendor Selection /li /ulh3Compensation and Benefits /h3pThe anticipated base pay range for this position is: €119,200.00 – €204,355.00. In addition to base pay, we offer 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. /p /p #J-18808-Ljbffr