Quality Manager Technology Transfer

il y a 3 semaines

Wavre, Belgique GSK Temps plein

**Site Name**: Belgium-Wavre

**Posted Date**: Jun 6 2023

**Job purpose**:

- In the context of GSK business growth, take responsibility for quality aspects (QA, QC, manufacturing and validation activities) within the groups of MSAT Technical Transfer and External Manufacturing Vaccines. Be accountable from Quality point of view to ensure a successful technical transfer between Third Parties, Out licensee and GSK sites.
- Maintain the compliance level with GMP regulations/requirements and GSK Biologicals standards within the Contract Manufacturing Operations (Third Parties).

**In this role you will**:

- Ensure appropriate quality oversight during technical transfer projects
- Be the quality contact point for the Third Parties in the context of Technology Transfer.
- Ensure that Quality systems are in place/in use, routinely monitored and assessed, and harmonized throughout the MSAT Technology Transfer and External Manufacturing Vaccines. departments and ensure Third Party management is in place in GSK for QA topics.
- Ensure accountability for all quality activities linked to the Technology Transfer projects to the third party management (deviations, CAPA closure, risks management,, product quality review, Quality Agreement and QA authorizations/Approval of transfer projects,) and take responsibility for the GMP and regulatory compliance through the transfer projects. Support Global Regulatory team to define the appropriate Regulatory Strategy associated with the project.
- Ensure and maintain good relationships with third party to guarantee win-win collaboration, through informal meetings, governance meetings and transfer projects related meetings. Availability to travel for face-to-face meetings at Third Parties site, when needed.
- Represent the QA EMV within various meetings, such as GSK audits or Health Authority inspections at Third Party site or at GSK. Report points and issues to direct manager and to perform an After Action Review
- Maintain knowledge and experience up to date in the light of technical and scientific progress and changes in quality management. Continuous Learning mindset to drive performance and continuous improvements using defined tools.
- Take transversal responsibilities for quality systems within the scope of EMV team, act as Subject Matter Expert (SME) if requested.
- Manage Questions & Answers and commitments linked to customer, GSK stakeholders and Third Parties requests in due time.

**Why you?**:
**Qualifications & Skills**:

- University degree in Pharmacy, Life Sciences, Bio Engineer
- Minimum 7 years’ experience in Pharmaceutical Industry
- Good knowledge of GMP’s, regulatory requirements and standards
- Good knowledge of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance
- Fluent in written and oral English.

**Preferred Qualifications & Skills**:

- Experience in QA/aseptic production is a plus
- Good interpersonal skills like communication, influence.
- Excellent organizational skills, effective time management, ability to clearly identify priorities and manage multiple tasks
- Ability to create and maintain networks.
- Creative approach to problem solving.

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.

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. 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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