Manager QC Validation Software & Validation Subcontractors Delivery

Contenido de trabajo

Site Name: Belgium-Wavre

Posted Date: Apr 16 2025

About The Role

In this role, you will:

Be part of the BE QC Equipment & System validation organization.

Be accountable to manage QC Validation Software activities Operations used in QC Environment, to manage Validation Subcontractors delivery & to be recognized as Analytical Software expert. Together with the validation team, he is accountable for the effective validation of Commercial off the Shelf Software, and to optimize Subcontractors delivery.

The purpose of this role is to develop, review, approve and coordinate deliverables to release Commercial of the shelf computerized systems for regulated use while ensuring compliance with internal procedures and industry guidelines, is to optimize Subcontractors delivery by oversighting their activities according Contract clauses, managing Outsourcing budget allocation according to Validation load distribution & potential operating benefit. Is to develop Validations knowledge on all QC Analytical Software to be recognized as Subject Matter Expert

The role requires agile and creative skills in order to match every quality and business constraints with Software Validation. He is accountable for the systematic approach to collecting and analyzing all the required data to give reasonable assurance and documented evidence that the processes and analytical methods will, when operated within specified parameters, consistently produce results within predetermined specifications. This includes Qualification (IQ), Operation Qualification (OQ), or Performance Qualification (PQ).

He/she ensures the adequate management of validation deviation and potentials CAPA

These activities are organized and delivered :

• with the highest quality in accordance with cGLP’s and EHS requirements
• by interacting efficiently with relevant internal partner: Support departments, QA,… & external Subcontratcors
  

In order to:

• Release commercial and non-commercial vaccine product
• Perform laboratory investigations during the development of new vaccine process
• Improve & promote productivity, added value and cost control
  

About The Responsibilities

• Be responsible for the coordination of Software Cost of the shelf Validation: establish Validation Strategy, follow and take decisions during the validation (from DQ to VSR).
• Be the expert of ALCOA++ requirements implementation for Software validation (GAMP5) -
• Be the analytical Technical Expert or Subject Matter Expert of validated QC softwares
• Improvement of Validation process, process rationalization in partnership with CSV QC Subject Matter Expert
• Be responsible for the QC of continuous validation activities: put in place/maintain the validated status of system: establish and execute CVP, coordinate Change Control, deliver validation services including IQ/OQ and PQ support (writing and review/approval of protocols, execute, manage deviation and out of specification investigation).
• Be responsible for the subcontractors management in term of :
• Budget Allocation based on validation load
• Optimize load distribution in term of operating benefit
• Optimize Internal & External relationship (Governance, Issue, Role & responsibilities clarification)
• Challenge Subcontractor Delivery based on performance indicator, suggest & implement Way of working improvement.
• Revise & Challenge Subcontractor bill.
• Support for ensuring inspection readiness regarding validation during internal GSK audits and external authority’s inspections and to assure follow-up related validation commitments.
• Participate in the evaluation of new standards: evaluate impact on local activities and integrate best practices.
• Allocate local support resources to global/major project to deploy in his department.
• Manage Deviation & CAPA linked to his/her activities
  
  

About You

• Hold a master’s degree in Science or Engineering or qualification by experience in a similar role
• Be able to understand the characteristics of GMP relevant Software used in a QC testing environment including their potential impact on product and patient safety.
• Be Expert in computer compliance standard (CFR, Eudralex, MHRA) data integrity ALCOA++ principle.
• Demonstrate excellent experience with Validation Subcontractor management
• Be able to use a risk-based approach for problem solving and prioritization of tasks
• Show good interpersonal relationship skills
• Demonstrate good oral and written communication skills in French & English
  

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 GSK?

Uniting science, technology and talent to get ahead of disease together.

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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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