Project Specific Issues And To Key Stake Holders
R&DQualityLead
“R&D Quality Lead at Project Specific Issues And To Key Stake Holders. Skills: Quality Assurance, Quality Management Systems, GxP Experience. Provide quality assurance and compliance oversight to development and research functions.. Drive the oversight of quality management systems and initiatives within the global, regional, and country organization, ensuring compliance with applicable health authority regulatory requirements (e. g. , GCP, GLP, GMP, PV, IP) and Novartis procedures and quality st”
What You'll Achieve.
Quality and timelines of strategic project documentation and presentations: Documentation available on time and of high quality; Reliable, timely and accurate information/communication about project specific issues and to key stake holders.; Deliver on departments costudget-Establish succession plan; Role Model of Novartis culture, values, & behaviours
Industry & Context.
root cause analysis
What They're Looking For.
Must Have
GCP, GLP, GMP, PV, IP
Nice to Have
English
What You'll Do.
Provide quality assurance and compliance oversight to development and research functions.
Drive the oversight of quality management systems and initiatives within the global
and country organization
ensuring compliance with applicable health authority regulatory requirements (e. g.
IP) and Novartis procedures and quality standards.
drive and/or support Quality plan initiatives in order to achieve organizational strategy
Provide QA expertise and guidance to ensure compliance with requirement of the quality system are met
including implementation of quality risk-based and GxP relevant process.
Lead and manage a QA organization and/or quality project team and collaborate with business partners and other quality groups to ensure health authority and regulatory requirements are fully met
Translate functional QA strategy into applicable operational/compliance activities and support a risk -based implementation and execution of processes.
Ensure quality and compliance gaps are addressed and executed for sustainability and implement strategic process improvement
including review of procedural updates
Monitor implementation of the Quality Plan and support inspection readiness activities
including participation in regulatory inspection preparation
management and follow-up.
Support quality oversight/management of external service providers and IT systems supporting research and development activities and drive facilitation and follow -up of audits and inspections
and ensure development
implementation and completion of appropriate corrective and preventive measures for findings
Ensure timely escalation of deviation/incidents and provide quality oversight for deviations/incidents
including robust investigations
root cause analysis and corrective actions implementation.
Contribute towards lessons learned based on audits
regulatory intelligence
effectiveness checks on process implementations and metrics and support a culture of proactive
risk -based behaviour
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
Distribution of marketing samples (where applicable)
How You'll Work.
Team & Collaboration
collaborate with business partners and other quality groups
Communication Scope
Reliable, timely and accurate information/communication about project specific issues and to key stake holders.
Process & Methodology
Quality plan initiatives, strategic process improvement, inspection readiness activities, audits and inspections, corrective and preventive measures, lessons learned
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