Senior Specialist, Third Party Quality

il y a 2 semaines

Rixensart, Belgique GSK Temps plein

**_Be You’ at GSK_**:
At GSK, we're a company with a purpose to **help people do more, feel better and live longer. **We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.

We will be delighted to hear from talented individuals that align to **our values. These **are at the heart of everything we do and include**:Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.**

**When you set out on your adventure at GSK, we make a deal. **You commit to living our values and expectations and performing against our **Innovation, Performance and Trust **priorities. In return, GSK commits to providing the **right environment for you to thrive. **Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a, we empower you to be yourself, share ideas and work collaboratively

**Senior Specialist, Third Party Quality**

Responsible for designing, developing and implementing Third Party Quality strategies to ensure an adequate Quality Assurance of the services provided to GSK Vaccines R&D, in compliance with GxPs and regulatory expectations.

Promote and implement a Quality and Safety culture within R&D.

**In this role you will**:

- Ensure QA oversight of third parties involved in the Clinical Manufacturing and Supply processes.
- Responsible for managing Third Party Quality processes that will ensure an adequate service provided to GSK Vaccines Technical R&D
- Ensure that GSK External third-party service providers (Warehouse / Carriers, CMO, GSK Sites, Comparators suppliers, etc.) comply with GSK quality requirements, cGMP and regulatory requirements
- Ensure the release of batches / data provided follow GMPs and regulatory requirements.
- Act as primary quality contact for the third parties he/she is responsible for and for the internal stakeholders involved in activities contracted to these third parties. Monitor and manage the quality performance of these third parties, and ensure they operate in compliance with GSK standards and requirements.
- Organize and manage the quality governance meetings for these third parties.
- Write, coordinate and ensure the follow-up of the quality contracts approval and update, when necessary.
- Ensure complaints, deviations, change control, CAPAs, validations related to third parties are handled in a timely manner and in compliance with cGMPs and Quality Contracts.
- Contribute actively in the third parties selection and approval process, as appropriate. Manage the approval status of these third parties.
- Ensure issues and risks are adequately identified, assessed, mitigated and escalated.
- Prepare and support the third parties release certification and re-assessment process. Review and approve all the required documentation for the batch release process.
- Ensure all the documentation related to these third parties is correctly reviewed, managed and archived according to GSK requirements.
- Collaborate in third parties audit organization, preparation and execution, as appropriate.
- Be part of the transfer team for product/process transferred from GSK to a third party and from a third party to GSK.

**_ This job opportunity is a permanent contract. Travel up to 10%_**

**_
Why you? _**

Qualifications & Skills:

- Master in biologicals sciences (microbiology, virology), or Bioengineer, or Pharmacist with Major in pharmacy, microbiology, chemistry or biochemistry
- 10-15 years of experience in a GMP environment
- Collaborative working: experience with teams and individuals in other functions/parts of the business, in a collaborative manner to develop effective solutions and create value.
- Experience in working in a cross-cultural environment, understanding similarities and differences, and adopting appropriate ways of working and communication, to achieve the desired outcome.
- Fluent in English.

Preferred Qualifications & Skills:

- Capacity to engage others, and work in a multifunctional team and ability to work with teams in other departments towards aligned goals
- Strong communication skills
- Influencing and negotiation skills
- High learning agility and analytical skills
- Flexibility and resilience, strong logical approach to problem solving, pragmatic and result driven with a ' can do' attitude.

**#Li-GSK**:
GSKTechTalent

**_ Why GSK?_**:
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 impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on ou

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