62 days ago on sjobs.brassring.com

Global Program Quality Lead

Novartis Pharma Schweiz AG

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Global Program Quality Lead

Job ID187437BRPosition TitleGlobal Program Quality LeadDivisionPHARMABusiness UnitPharma QACountrySwitzerlandWork LocationBaselCompany/Legal EntitySwitzerland Novartis Pharma AG, BaselFunctional AreaQualityJob TypeFull TimeEmployment TypeRegularJob DescriptionLead the implementation of the quality strategy closely aligned with the business strategy within the Oncology Global Business Unit. Provide strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Global Head Oncology QA. Within assigned GPTs, facilitate the implementation of a risk based quality management process fully embedded through trial design, execution and submission including all vendor managed business setups with the objective of achieving the highest data quality standards, full adherence to patient’s rights and well-being and in support of successful Health Authority inspections and approvals. Lead in a proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for all GxP matters for the Global Program Head and the Global Program Team. Provide operational QA leadership for the respective GPTs, including Quality Oversight for the Quality Plan execution, Health Authority Commitments, Critical Incidents incl. respective escalation process and the CAPA Management Process for the respective business areas.
- Facilitate implementation of the quality strategy in close alignment with the GPT strategy. Monitor and track implementation and break-down of the annual Quality Plan with the supported GPTs - Support the Oncology QA Head with Quality Review Board(s), ensure appropriate management review of relevant topics, including KQIs. Identify continuous improvement initiatives for quality and compliance areas. - Interact with senior Oncology leadership teams to ensure Quality is consistently and proactively represented in support of a quality risk management process. - Interact with eClinical QA and the respective Data Management groups and respective CROs to ensure high data quality and proactive detection and resolutions. - Support strategic GPT Quality & Business initiatives, including activities for quality risk assessment and submission-critical trials and the development and implementation of strategic process improvement. - Lead communications on GxP topics/issues within the GPT, along with Oncology QA Head and other Dev QA heads. - Help ensure applicable clinical development processes and quality standards are in line with worldwide HA requirements. - Monitor effectiveness of applicable clinical development processes through KQIs in collaboration with business process owners - Implement and lead the process to regularly review and assess KQIs at the respective GPTs, and prepare respective management documentation for the Franchise QA Head for review at the Quality Review Boards. - Provide/ensure Quality oversight, including adequate and timely escalation of incidents/issues; quality oversight for deviations/incidents & investigations and ensure adequate CAPAs are defined; proper quality oversight for 3rd parties/vendors/outsourced activities; implementation of enhanced self-assessment/self-inspection process; oversight of adequate training within the respective GPTs. - Ensure inspection readiness for the respective GPTs; facilitate respective regulatory inspection preparation, management, systems and process support and follow-up. - Support Global and Regional Clinical Ops Heads with Quality input and oversight of clinical trials. Liaise effectively with Global CPO QA to ensure GCP requirements are adequately considered in the planning and conduct of clinical trials. - Support cross-functional implementation of the Strategy, and Vision and Mission of Pharma Dev QA.
Minimum requirements• Degree in Life Science, Pharmacy or Medicine is required. Preferably Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines
• English
• At least 5 years of involvement in regulated activities, clinical oncology development and QA leadership positions;
• Broad understanding of global expectations of Health Authorities in Clinical Development;
• Profound understanding of Pharma product development
• At least 8 years demonstrated accomplishments in a global/matrix in the pharmaceutical industry;
• At least 5 years’ experience in leading/managing (global) projects;
• Strong leadership, interpersonal, communication, negotiation and problem solving skills;
• Ability to work independently and in a team environment;
• Demonstrated experience and proven track record of successfully leading projects;
• Ability to effectively interact with and present to senior management, as well as to external audiences and inspectors;
• Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams
• Note: Position can be filled in East Hanover or Basel