TQ&C Global Delivery ServicesRegional Europe team works closely with the Technology Quality ComputerizedSystem Validation (TQ-CSV) Center Of Excellence to ensure compliance of systemsacross the enterprise in accordance with J&J SDLC, assures compliancewithin the enterprise with applicable global regulations, advise on qualitymatters, and assist with closing compliance gaps related to audits andinspections.
The Sr Manager TQ - ERP / WMS isresponsible for managing end to end programs / projects across the Enterpriseand ensure that the project goals are delivered as per business expectationsand J&J Quality standards and procedures.
MajorDuties and Responsibilities + The role isto provide technical and procedural expertise / guidance to the project teams aswell as aligning with both internal and external stakeholders.
Thisposition will support internal and external Health Authority regulatory audits. + Thisposition will be responsible for the approval of SDLC validation documentationdeliverables including the approval to release system implementation and / orchanges for production use, will attend Project Team meetings and provide CSVcompliance guidance and support to project and base business support teammembers.
Responsiblefor the development of direct reports by supporting the development of HumanResources Planning (HRP) programs including management development and trainingto meet current and future business needs.
Responsible for managing end-to-end programs / projects withinthe ERP / WMS space from a CSV perspective + Ensure a high degree of Inspection Readiness for Systems in TQ'sportfolio with the purpose of minimizing the risk of inspection observations toBusiness systems / infrastructure within TQ's responsibility + Provide CSV guidance and support to project and / or basebusiness teams in the resolution of validation documentation corrections and / ortest defects + Utilizes knowledge of the assigned business functions toidentify business needs and develop compliant solutions + Participate in audits, approves audit non-conformity actionplans and approve closure of internal audit findings + Assist with incidentmanagement / CAPA and NC for the systems supported.
Supports the allocation of resources by accuratelycommunicating availability + Responsible for managing budget for CSV Program / Project / BaseBusiness + Works collaboratively with project teams to keep theminformed of project status, including any barriers + Proactively monitors systems and processes to ensurecompliance with standard operating procedures, audit compliance and industrybest practices + Utilizes expert knowledge regarding IT Quality risk managementpractices and leads and mentors a team through the system lifecycle + Responsible for managing resources(both internal andexternal) and ensure availability for ongoing and upcoming initiatives / projects + Develops and communicates compelling, fact-based rationalethat build support for one's perspectives and initiatives cross-functionally,and helps others to do the same + Provides partnership, insight and direction tocross-functional business leaders and stakeholders regarding CSV policies, solutionsand initiatives + Builds and maintains trusting, collaborative relationshipsand partnerships with internal and external stakeholders which help accomplishkey business objectives, and helps others to do the same + Partners with key stakeholders to assess, develop andimplement solutions to meet their business need + Clearly communicates with Stakeholders to set expectations onthe feasibility and timeframe for the delivery of solutions and when qualitystandards are not met + Demonstrates an understanding of many relevant Quality andCompliance Principles and their applications + Utilizes knowledge of relevant Quality and Compliance areasto recommend existing solutions to business.
Proactively monitors processes to ensure compliance withstandard operating procedures, audit compliance and industry best practices.
Responsible for the development of direct reports bysupporting the development of Human Resources Planning (HRP) programs includingmanagement development and training to meet current and future business needs + Providean environment which encourages the company's credo, commitment to equalemployment opportunity and the value of a diverse work force + Perform other work relatedduties as assigned Other Duties + Develop andmaintain an effective working partnership with senior management.
Mentortalent and help them grow in their careers. + Collaboratewith other leaders and staff within TQ's group to ensure each function is executedin an efficient manner.
Ensuretimely reports of status, metrics and time sheets as required by the TQorganization + Ensure timely completion ofassigned training and expense reports Qualifications + A Bachelor's degree in Computer Science, Information Systems,Business Administration or other related field required;
advanced degree preferred;solid, relevant experience may be substituted when appropriate; additionalcertifications a plus + A minimum of 10-12 years of progressive experience in thepharmaceutical / med device / biotech industry, with direct experience inComputerized System Validation activities + Experience authoring or approving validation protocols,Non-conformities, Change Requests, SOPs, Validation Plans and Reports isrequired + Strong QA analyst skills with experience in ComputerizedSystem Validation in GxP environments in the pharmaceutical industry required + Expert project management and organizational skills arerequired + Must have the ability to make decisions by seeking out andmaintaining trusting and collaborative relationships to meet business needs anddemands + Must have the ability to work effectively in a highlymatrixed team environment + Demonstrated leadership capabilities required + Working knowledge of PMO,SDLC, GAMP 5, and ITIL frameworks is highly desirable.
Thorough knowledge of cGMP,GCP and GLP regulations related to CSV, including 21 CFR Part 11, Annex 11 isrequired + Working knowledgeof Global standards such as International Conference on Harmonization(ICH.
andInternational Organization of Standards (ISO) preferred + Experience in Testing Management tools like HPALM + Experience in running large scale end-to-end Validation programs.
Experience with CAPA, MES, PLM, SAP, LMS, Complaints Handling and Change Control systems is desirable + Superior written andoral communication skills required + Excellent skills with Microsoft Office required + Knowledge of Quality Management process and ComputerizedSystem Validation principles a plus + Strong skills in interdependent partnering and influencingrequired + The ability to find new ways to come to the same goal andpragmatic advising striving for the optimal solution ensuring compliance in acost-effective way required + Must have the ability to perform work with a high degree ofindependence in terms of self-management of a large variety of tasks andinitiatives regarding Quality + Must have the ability to independently determine and developapproach to solutions and may determine long-term solution + Ability to manage multiple and competing projects isrequired.
Primary Location Belgium-Antwerp-Beerse- Other Locations Europe / Middle East / Africa-Switzerland Organization Janssen Pharmaceutica N.
V. (7555) Job Function Info Technology Requisition ID 00001FYW