87 days ago on sjobs.brassring.com

Head Engineering Compliance

Novartis Pharma Schweiz AG

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Head Engineering Compliance

Job ID192123BRPosition TitleHead Engineering ComplianceDivisionPHARMABusiness UnitGlobal Tech OpsCountrySwitzerlandWork LocationBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaTechnical OperationsJob TypeFull TimeEmployment TypeRegularJob DescriptionLeads a team of specialists to ensure engineering quality and compliance in projects and in operations within Global Engineering and at all NTO Sites.
•Provide technical & compliance support to sites & global organizations regarding all facility, utility & equipment systems.
•Conduct regular site of Rolling Engineering Assurance reviews.
•Enable & facilitate the sharing & leveraging of local best practices in commissioning, qualification, maintenance, calibration, change management & training.
•Train & support site Compliance Engineers in implementing GxP & Global Engineering compliant solutions.
•Support the sites by global harmonized, efficient engineering processes.
•Assist sites in preparation, review & approval of responses to internal & external CGMP audits.
•Stay abreast of regulatory & industry standards by participation in professional organizations, peer groups, seminars and literature. Develop corporate positions & policies for continued compliance of facilities & equipment.
•Act as primary Global Engineering liaison to Divisional & Group Quality.
•Global Subject Matter Expert for engineering quality assurance & engineering compliance issues.
•Support & interpret Quality Manual entries related to facilities & equipment.
•Drive engineering quality improvements via global KPI & according procedures.
•Direct the equipment vendor quality program. Ensure that vendor internal quality systems are adequate to meet Novartis user requirements & engineering specifications & that vendor documentation is accurate & specific to Novartis needs.
•Develop talents in Engineering Compliance.
•Lead & maintains a Novartis Best Practice Network in Engineering Compliance.
•Support GxP Training for Global Engineering personnel.
•Ensure that engineering quality is considered, required & built into all projects. Maximize “right first time” concept to eliminate redundancy & low value activities.
•Ensure appropriate reviews are undertaken to clearly identify the boundaries of Direct Impact/Non Impact systems & regulatory compliance & engineering quality assurance through Quality Needs Assessments, Qualification Master Plans or other means.
•Establish lines of communication with the User and Quality units to ensure that designs are understood & approved.
•Ensure that Engineering Quality Assurance is considered in the contractor pre-qualification & selection process.
•Provide engineering quality audits of project team & contractor performance.
•Ensure that the qualification activities are established according Global Engineer-ing guidance. Develop, if required, and/or support qualification and validation plans.
Minimum requirementsDegree in engineering (Dipl. Ing. or M.Sc. or B.Sc.) or equivalent English essential, German preferable, others helpful.
•15 years of general engineering experience thereof +10 years experience in a pharmaceutical manufacturing environment.
•10 years experienced in Validation I Qualification in regulated pharmaceutical environment.
•Outstanding Technical knowledge with demonstrated ability to deliver safe and fully compliant technical solutions.
•Demonstrated Leadership abilities leading a team aligned around business/technology/project processes.
•Well-developed communication skills, able to present comfortably to Senior Management and to Technical experts.
•Demonstrated with knowledge/understanding of key non-technical business processes, Human Relations, Finance.
•Advanced HSE and GxP/QA knowledge.