208 days ago on axepta.ch

Global Quality Assurance Director (GxP)

AXEPTA SA

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 Please refer to JobSuchmaschine in your application

Global Quality Assurance Director (GxP)

Global Quality Assurance Director (GxP)

My client is a small niche international pharmaceutical company based in the French part of Switzerland.

 

Due to this growth, my client is looking for a Global Quality Assurance Director (GxP) to join their team in the French part of Switzerland.

 

 

Responsibilities:

  • Implementation of quality management systems (QMS) strategies, policies and procedures to meet worldwide pharmaceutical quality systems requirements.
  • Manage a QA team at international level
  • Execution, coordination and tracking of all QMS procedures and related activities including (but not limited to) internal audits, external audits, change management, document management, training management, batch review/release, annual product reviews, deviation investigations, complaints, recalls, regulatory inspection management, quality risk management and management review coordination.
  • Coordination of supplier approval and set-up processes, including conducting audits and reviewing quality agreements.
  • Development and implementation of collaborative strategies to work as part of a multi-disciplinary team to ensure quality and compliant outcomes in a timely and cost-effective manner.
  • Implementation ofglobal product quality and compliance strategies for development-stage programs and marketed products.
  • Provide quality and compliance guidance and training on policies and procedures impacting commercial and development operations

 

Your profile:

 

  • Degree in pharmacy, pharmaceutical sciences, chemical engineering, chemistry or a related life sciences discipline
  • 15 years of direct experience in the quality assurance/QMS aspects of both pharmaceutical product development and commercialization
  • International experience is a must
  • Leadership and Line management experience
  • Experience with quality assurance/QMS systems
  • Broad knowledge and direct hands-on experience in all contemporary global GxP requirements (i.e., GMP/GLP/GCP/GDP/GVP).

Please contact Noemie Oliva at noliva@axepta.com for more information