Are you a clinical quality professional looking to lead and build a GCP function within a valuable, young organization? Have you previously implemented strategy, built key stakeholders and process framework? Do you have the energy and passion to set a plan and really drive it to create a critical function within an organization?

I am working with one of the world’s most valuable biotechnology organizations. They currently have over ten clinical programs and this will double by the end of the year. They are innovative and research-driven, over half of the clinical programs are their own developments. This organization are investing just as much into digital AI as they are in research.

The Director/Senior Director is the vital leader that will be bold with their approach to build and lift a new function within a fast moving, young organization.

They are looking for an experienced GCP Quality professional to join the team. This opportunity provides a great platform for an individual to make a difference and play an essential part in bringing some of the most exciting, innovative new therapies to market.

It is an opportunity for the Director/Senior Director to implement their ideas and strategies to lift and build a successful GCP function.

Objectives:

If you impress during the hiring process and are offered the job, these will be your objectives:

Build the GCP function

  • This position will see you implementing strategies, building key stakeholders and process framework to build the GCP function

Collaborative Working

  • Be a strong collaborator across multiple functions and have a hands-on approach to leading and building the GCP team

Subject Matter Expert for GCP

  • Provide guidance, ensure compliance and facilitate and develop training for personnel

Responsibilities:

You will be expected to perform the following tasks and duties:

  • Develop and implement standards, policies and procedures for GCP compliance
  • Review and produce protocols, method validations and study reports
  • Present quality data and metrics and advise senior management of issues and provide corrective actions
  • Organize and lead all GCP audit activities
  • Provide information on GCP regulations, standards and quality systems

Requirements:

You will possess the following skills and attributes:

  • 10+ years’ experience in Biotechnology or pharmaceutical
  • Extensive experience in auditing
  • 8 + years’ experience in quality systems related to GCP
  • Strong analytic skills
  • Working knowledge of FDA and global regulatory compliance

 

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