Job Purpose

As member of the Vx Clinical Laboratories QMS and EHS Strategy & Operations leadership team, the Head Documentation Excellence & Training Leader has to:

• Develop, adapt and implement standards/processes for Documentation Excellence & training strategy within Vx CL&AP.
• Ensure that documentation is accessible, up-to-date and complies with quality standards.
• Act as the Vx CL&AP business representative for Documentation Excellence (including written standards) & training interfaces (Q4R&D/QSS, GQA quality document management systems, RA …)

Key Responsibilities

• Lead the Documentation Excellence and training team (including the clinical lab support specialists)
• Lead Vx CL&AP documentation, Written Standards & Training (WST) strategy and represents Vx CL&AP in WST governance.
• Ensure optimal transversal documentation strategy and management within Vx CL&AP
  • o Develop and maintain processes to manage official Vx CL&AP documentation (e.g.: Memos, Qualification &Validation protocols & reports, answers to questions from Authorities, , …)
  • o Act as the business representative for documentation excellence interfaces (Q4R&D/QSS, GQA quality document management systems, RA…)
• • Ensure optimal UE,CAPA & change control processes within Vx CL&AP
• • In connection with Vx CL&AP stakeholders and Q4R&D WST:
  • Ensure the team is applying processes and good practices according to GCP/GCLP and ISO 9001- 2015 requirements
  • ensure simplification and harmonization of training matrices content across Vx CL&AP
  • With QSS, review the design of training programmes for employees, using a variety of formats such as online courses, face-to-face sessions, etc.
  • Plan and coordinate the implementation of training programmes, working closely with QSS and team managers.
  • Evaluate the effectiveness of training programmes and adjust content based on feedback and changes in business needs.
  • Carry out regular self inspections of documentation to ensure compliance and quality Ensure management of Vx CL&AP personnel documentation (e.g.: such as CVs, JDs, Signatures, Org charts) and  
  • Ensure eTMF local expert for Vx Clinical Laboratories & Assays Portfolio to provide end users support
  • o Act as the business representative for training strategy interfaces (Q4R&D/QSS, EHS, GCO (eTMF,…)…
  • Support continuous improvement in quality and compliance aspects, associated to documentation and training management, by contributing to the development of new processes, changing existing processes and procedures

 Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Master degree or at least 10 years experience in Clinical laboratories

Excellent written and oral communication skills

Ability to work independently and collaborate with various departments.

Mastery of content creation tools and e-learning platforms.

Ability to manage several projects simultaneously.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• PhD or at least 10 years experience in Clinical laboratories

*Li-GSK

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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