Senior Manager External Service Provider (m/f)

Division Global Drug Development
Geschäftseinheit QA GDD
Standort Oberhaching (near Munich)
Funktionsbereich Quality
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 244191BR


Stellenbeschreibung

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).

• 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.
• Deputizes for the GDQ governance board chair.
• Responsible for all relevant vendor oversight activities as outlined in oversight procedures.
• 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.
• Owner of the key quality attributes metrics database
• Coordinates Metrics collection, monitoring and reporting including follow-up with LF and escalation
• Responsible for collection of KQIs from the Novartis QA databases globally and monitors them for all ESPs on a monthly basis.
• Report metrics to the ER Leads and GDQ Management on a quarterly basis
• Follows-up on overdue metrics with QA responsible and external relation (ER) Lead so the ERMT Teams can follow-up accordingly.
• Reports metrics to the ERMT Leads and GDQ Management on a quarterly basis and follows-up on concerns and issues until closure.
• Provides support for internal and external audits and inspections. Ensures inspection readiness at all times.
• Ensures compliance with regulatory requirements (including record management) and continuous improvement of quality relevant processes within area of responsibility.



Quality


Mindestanforderungen

• 5+ years working experience in pharmaceutical development and excellent knowledge of the technical development and clinical operations processes and vendor related activities.
• Minimum a Bachelor degree in Life Sciences, Pharmacy or Medicine, or other related discipline required.
• 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 international and 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 and interpersonal skills.
• Self-motivated with a high degree of ownership and responsibility for results
• Fluent English (oral and written)

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.
Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.



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