P pAt 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. /p pAs 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. /p h3Job Function /h3 pQuality /p h3Job Sub Function /h3 pClinical Quality /p h3Job Category /h3 pPeople Leader /p h3Locations /h3 pAllschwil, Basel-Country, Switzerland, Allschwil, Switzerland /p h3Job Description /h3 pThe 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. /p h3You Will Be Responsible For /h3 h3People Leader Responsibilities /h3 ul liEstablishes goals and objectives for CRM Representatives. /li liPerforms mid-year and end-of-year review for CRM Representatives. /li liAssists in outlining and evaluating career development goals with CRM Representatives. /li liWorks with team members to establish workstreams to update processes for efficiency and maintaining inspection readiness. /li liCoordinates upskilling knowledge workshop series for CRM Representative team development. /li /ul h3Risk Management /h3 ul liEnsures 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. /li liEnsures a consistent quality risk assessment process across the program. /li liProvides and leads strategic guidance to CRM representatives on quality risk assessments, risk entries, and mitigation strategies. If assigned, approves CQP (Clinical Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews. /li liIndependently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews. /li liEnsures a strategic communication framework with business partners and quality management governance to keep them informed on key quality risks and mitigations. /li liCommunicates and facilitates risk updates to RD Business Partners as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable. /li liWorks with risk owners to develop effective risk mitigation plans to control risks in the trial level CQP. /li liHighlights new potential systemic risks to RDQ / CRM management. /li /ul h3Issue Consultation, Issue Escalation, and Compliance Assessment – In consultation with the Head of Clinical Risk Management /h3 ul liDevelops and ensures a consistent interpretation of issues that require quality investigations. /li liProvides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior RD management. /li liProvides initial serious breach evaluation of quality issue that may require reporting to Health Authorities. /li liIn 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 /ul h3Inspection Readiness And Support /h3 ul liIndependently 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. /li liProvides front and back‑room support for Sponsor‑Monitor inspections at JJ Sites including post‑inspection support. Provides inspection support per contractual agreement for third‑party inspections (vendors, co‑development partners and contract research organizations). /li liProvides remote support for investigational site inspections including post‑inspection support. /li liProvides mentorship and/or coaching for others on inspection support and readiness. /li /ul h3Consultancy /h3 ul liProvides 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 /ul h3Post‑licensing And Acquisition (LA) / Integration (where Assigned) /h3 ul liSupports 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 executes assigned responsibilities per plan. /li liProvides and leads general guidance to stakeholders. /li liAs required, provides, and leads input into Quality Agreements with (Co‑)development Partners and executes responsibilities per agreement. /li liSupports and facilitates asset divestment. /li /ul h3Requirements / Qualifications /h3 ul liMinimum of a Bachelor’s degree (scientific, medical, or related discipline) is required. /li liMinimum of 10 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 pNOTE: This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. We recommend focusing on the specific country(s) that align with your preferred location(s). /p /p #J-18808-Ljbffr