A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Senior Manager ESP QA
Position Purpose
Manage implementation of quality standards, processes, tools and systems used in managing external service providers (ESP) across GxP areas in GDQ. Responsible for QA ESP oversight activities across Global development Quality (GDQ), supporting and managing activities of the ESP GDQ governance board to ensure risks and trends are evaluated to identify potential quality and performance issues in a proactive manner and to facilitate escalation to GDQ management and External development Operations (EDO) organization including follow-up until risks are mitigated and relevant actions closed. Deputizes for the Chair of GDQ External Service Provider governance board. Single point of contact for reviewing related standards in QA agreement with ESP to coordinate and share information across groups and to ensure processes are implemented, metrics are reported and followed-up on to achieve a holistic landscape of ESP across GDQ. Effective collaboration with assigned EDO partners (EMRTs), responsible for day-to-day ESP operations and oversight. Assures the quality and compliance to regulatory standards of outsourced activities within respective/assigned (GxP areas).
Major Accountabilities
1. Coordinates and manages external service provider GDQ governance board activities to enable evaluation of KQIs, to detect risks, trends and to identify potential quality and performance issues with the ESP in a proactive manner.
2. Deputizes for the GDQ governance board chair.
3. Responsible for all relevant vendor oversight activities as outlined in oversight procedures.
4. Collaboration with GDQ, EDO and procurement departments to ensure their involvement in the risk evaluation and timely communication to the business and follow-up on required actions.
5. Owner of the key quality attributes metrics database
6. Coordinates Metrics collection, monitoring and reporting including follow-up with LF and escalation
7. Responsible for collection of KQIs from the Novartis QA databases globally and monitors them for all ESPs on a monthly basis.
8. Report metrics to the ER Leads and GDQ Management on a quarterly basis
9. Follows-up on overdue metrics with QA responsible and external relation (ER) Lead so the ERMT Teams can follow-up accordingly.
10. Reports metrics to the ERMT Leads and GDQ Management on a quarterly basis and follows-up on concerns and issues until closure.
11. Provides support for internal and external audits and inspections. Ensures inspection readiness at all times.
12. Ensures compliance with regulatory requirements (including record management) and continuous improvement of quality relevant processes within area of responsibility.
Key Performance Indicator
1. Satisfied key stakeholders (GDQ, EDO, procurement)
2. Concise, timely collection and reporting of KQIs and supporting reports
3. Efficiency in the management and timely follow-up on the ESP governance board activities to support the evaluation of issues, resolution, escalation, and communication
4. Ability to timely produce appropriate documentation and evidence during audits and inspections
5. Contribute to continuous improvements/enhancements to benefit business.
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Candidate Profile
Minimum a Bachelor degree in Life Sciences, Pharmacy or Medicine, or other related discipline required. Fluent English (oral and written)
• 5+ years working experience in pharmaceutical development and excellent knowledge of the technical development and clinical operations processes and vendor related activities.
• Good knowledge of GCP GMP, GVP.
• Demonstrated leadership in implementing robust processes and quality systems, and setting global quality standards in a regulated area, including controlled documentation for the pharmaceutical development area.
• Experience in managing third parties vendors and knowledge of quality standards requirements.
• Thorough technical understanding of specifications setting, collecting, analyzing and monitoring.
• Experience in data analysis and trending using Microsoft based or other tools.
• Demonstrated effective management and establishment of successful cross-divisional collaborations.
• Demonstrated root cause analysis skills
• Ability to work in a global team and matrix structure organization, meet timelines and work with minimal supervision
• Excellent communication
Additional Information:
Experience: 5+ years
Qualification : B.Pharm, B.Sc
Industry Type: Pharma
Functional Area: Global Drug Development
Job ID: 242264BR
Last Date: 1st July, 2018
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