Novartis
GCPComplianceManager(EMEAHub)
Neural analysis suggests this role is
optimal for Senior candidates.
“GCP Compliance Manager (EMEA Hub) at Novartis. Skills: GCP Compliance, compliance oversight, control of regulated GCO activities, issue management, audits & inspections, risk management. Accountable for the compliance oversight and control of regulated GCO activities focusing on EMEA Hub & Country level delivery including country trial level conduct as per country assignment.. Single point of contact for EMEA Hub & Country team members for GCP Compliance.”
What You'll Achieve.
promoting a product quality culture within GCO; quality and compliance being increased and sustained; active risk management; ensuring the detection of unreported issues, trends and early signals of risks at Hub & Country level; Promote a compliance culture within GCO, advocating the adherence to highest standards and ethical integrity.
Industry & Context.
Organizational and analytical skills; Critical thinking ability; risk management and risk-based knowledge and mindset; investigation; RCA
What They're Looking For.
Must Have
8+ years industry experience specifically in clinical operations and clinical site management, understanding of clinical research international standards and regulatory requirements from Health Authorities, Organizational and analytical skills associated with an aptitude in quality management and continuous improvement, Critical thinking ability and risk management and risk-based knowledge and mindset, Ability in partnering with a proactive and solution-oriented mindset, skills to facilitate/optimize contribution of team members as individuals and members of a cohesive team, Ability to work effectively in a matrix cross-functional environment, capacity for working independently with minimal guidance, Ability to make & communicate difficult decisions, associated with written and verbal communication skills, Self-awareness, willingness to further develop own strengths and explore opportunities for improvement
Nice to Have
Audits and inspections experience highly desirable
What You'll Do.
Accountable for the compliance oversight and control of regulated GCO activities focusing on EMEA Hub & Country level delivery including country trial level conduct as per country assignment.
Single point of contact for EMEA Hub & Country team members for GCP Compliance.
Management and day-to-day support provided in program/trial level quality issues
deviations and quality events management.
Coordination and support to program/trial delivery teams for audits and inspections based on trials’ selection and audit/inspection scope.
Delivery of the GCO self-assessment strategy related checks and controls.
Support cross-functions risk assessments if program/trial/country level in scope and contribute to the monitoring of relevant indicators/metrics/thresholds.
How You'll Work.
Team & Collaboration
Single point of contact for EMEA Hub & Country team members, providing day-to-day support and ongoing quality oversight.; working closely with the Hub & Country teams members, the relevant functions across GCO, involving and collaborating as required with GDD and the wider organization, such as Quality Assurance.; Involve and collaborate as needed with the relevant functions across GCO, GDD and the wider organization, such as Quality Assurance.; working closely with Quality Assurance.; Support cross-functions risk assessments if program/trial/country level in scope, working with Hub & Country Teams and the relevant GCO functions.; Participate in relevant GCO, PTC, GCP Compliance team meetings.; May attend as needed or be delegated by the GCP Compliance Head (EMEA hub) to participate in relevant boards, committees and escalation meetings (e.g. GCO Quality Review Issues Management & Escalations Triaging Meetings).; Contribute to build a network of managers and other relevant stakeholders with other functions, compliance, process, training and risk groups across GCO, in GDD and within the wider organization, such as Quality Assurance.
Communication Scope
written and verbal communication skills; make & communicate difficult decisions
Process & Methodology
program/trial level quality issues, deviations and quality events management, audits and inspections, CAPA development, CAPA & effectiveness checks completion
Full Job Description
**Band** Level 5 **Job Description Summary** The GCP Compliance Manager (EMEA Hub) is accountable for the compliance oversight and control of regulated GCO activities focusing on EMEA Hub & Country level delivery including country trial level conduct as per country assignment. This role contributes to all compliance activities supporting the three pillars of GCP Compliance, issue management, audits & inspections as per country assignment and GCO self-strategy delivery. The GCP Compliance Manager (EMEA Hub) is the single point of contact for EMEA Hub & Country team members, providing day-to-day support and ongoing quality oversight. This role promotes a product quality culture within GCO supporting the GCP Compliance Head (EMEA hub), focusing on quality and compliance being increased and sustained and on active risk management. **Job Description** **Major accountabilities:** * Accountable for the compliance oversight and control of regulated GCO activities focusing on EMEA Hub & Country level delivery including country trial level conduct as per country assignment. * Single point of contact for EMEA Hub & Country team members for GCP Compliance. * As per focus area and assignment, management and day-to-day support provided in program/trial level quality issues, deviations and quality events management. * Coordination and support to program/trial delivery teams for audits and inspections based on trials’ selection and audit/inspection scope. * Delivery of the GCO self-assessment strategy related checks and controls. * Support cross-functions risk assessments if program/trial/country level in scope and contribute to the monitoring of relevant indicators/metrics/thresholds. **Activities & Interfaces:** * Contribute to the execution of the GCO GCP Compliance strategy under the leadership of the GCP Compliance Head (EMEA Hub). * Drive the compliance oversight and control of regulated GCO activities focusing on EMEA Hub & Country level delivery including country trial leve
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