30 days ago on sjobs.brassring.com

Country QA Region Europe Head

Novartis Pharma Schweiz AG

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Country QA Region Europe Head

Job ID196289BRPosition TitleCountry QA Region Europe HeadDivisionPHARMABusiness UnitPharma QACountrySwitzerlandWork LocationBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaQualityJob TypeFull TimeEmployment TypeRegularJob DescriptionEnsure that , through influence of senior business leaders, all quality relevant processes within the Pharma Region Europe CPOs (31) are compliant and that non-compliance is appropriately addressed via corrective and preventive actions (CAPA) and/or escalation of issues.

1. Drive the implementation of a consistent quality culture across the Region Europe CPOs. 2. Influence and educate senior business leaders in Region Europe to help them understand the importance of Quality. 3. Lead the implementation of applicable Quality Standards in the Region Europe CPOs. 4. Lead, manage and develop talent, in conjunction with Regional Managers, a quality team of about 200 staff. 5. Ensure activities related to commercial batches and investigational medicinal products are managed in a compliant way. 6. Ensure that relevant SOPs are aligned to European regulatory requirements. 7. Ensure successful GxP regulatory inspections and internal audits of the CPOs. 8. Ensure the delivery of the Region Europe's Quality Plan and key Quality Indicators.

1. Performance against Key Quality Indicators. 2. Delivery of the Quality Plan. 3. Delivery of the budget. 4. Progress against Quality Risk Assessment. 5. Performance against HR metrics, e.g. completion of talking talent actions.
Minimum requirementsDegree of PhD in Life Sciences, Pharmacy or Medicine. Eligible to be a Qualified Person in EU preferred. Fluent in speaking / writing in English. Ability to speak another language used in the region preferred. 10-15 years experience of Quality Assurance, with in depth experience in one of the GxPs, e.g. GMP, GCP, PV Preferred experience of all GxPs. 5 plus years experience of leadership, preferably in a regional/matrix environment.