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Job ID 213103BR Position Title Director Clinical Quality Division NIBR Business Unit CFO Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Quality Job Type Full Time Employment Type Regular Job Description 1. Pro-active end to end quality oversight in the following areas of clinical
‐ Providing clinical quality operational oversight and regulatory guidance for day to day questions arising from clinical trials deliverables.
‐ Proactively supporting / collaborating with key stakeholders to conduct risk
assessments for the detection and remediation of risks and to ensure that clinical
trial processes are in control.
‐ Establishing/ leading governance for deviation/incident management pertinent to NIBR clinical areas and ensuring timely escalation when required.
‐ Supporting submission readiness and inspections preparation & facilitation
activities for assigned clinical areas in collaboration with other QA functions.
‐ Supporting/leading audits and inspections follow-up activities including CAPA
preparation, review, effectiveness and closeout activities.
‐ Providing Lessons learned from deviations/incidents, audits and inspections.
Pro-actively reviewing outcomes/trends to sustain improvement in clinical
processes and trial conduct in collaboration with other QA functions.
2. Provides expert knowledge for the wide range of exploratory research activities (collaborations/ acquisitions, non/low intervention studies) in order to ensure compliance regulatory requirements and overlap/interdependence with the GCP areas for the fast changing research environment. Lead/support evaluation of existing clinical processes across NIBR for the identification of risks and potential gaps to Novartis and regulatory requirements. Work effectively in a matrix environment with stakeholders to prioritize, develop, and implement plans to address these gaps and ensure sustained compliance.
3. Regularly monitor the implementation of the annual Quality Plan pertaining to the Clinical chapter, supporting business partners and assist with achieving deliverables per set targets.
4. Collaborate with internal partners and other Novartis functions to drive Quality
initiatives relevant to internal monitoring and outsourced activities oversight.
5. Interact with internal and external functions to support implementation of
activities from regulatory intelligence that impacts the NIBR organization.
6. As the CQL assigned for the assigned franchise(s), participate and present
outcomes in key governance meetings such as quality review boards, identifying
quality areas of focus, gaps and actions with the relevant stakeholders and
implementation and monitoring of effective KPIs.
7. Attend the key governance Leadership meetings and ensure that Quality
discussions are part of the key agenda topics on a monthly and quarterly basis
to support the QRB meetings.
8. Coach and advise new clinical Quality associates in the team as assigned by
manager. Minimum requirements ‐ Degree in Life Sciences, Pharmacy or Medicines. Advanced degree preferred. ‐ Excellent oral and written English communication skills
- Demonstrated experience with a minimum of 10 years working in a global/matrix environment in the scientific /pharmaceutical/biotech industry; 5+ years of which with involvement in regulated activities, clinical trials and QA (preferably) leadership position.
- Broad understanding of global expectations of Health Authorities in the area of Clinical development and GCP regulations
‐ Strong leadership experience including excellent communication,
collaboration/consensus building, considerable organizational awareness,
influencing and negotiation skills.
‐ Demonstrated ability to partake or lead interdisciplinary projects, work in global
cross-functional matrix, and to effectuate change within a high-performing
‐ Experience in coordinating/integrating with a wide range of business functions and
successfully work globally.
‐ A clear sense of personal accountability, an ability to empower people, ability to
drive quality culture with partners and a high degree of mutual respect and
integrity are essential factors to succeed.
‐ Strong office IT skills including MS Office suite.