Sr. Manager TQ - ERP/WMS
J&J Family of Companies
Beerse, BE
5 dagen geleden
source : DirectEmployers Association

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

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