Senior Manager QA for Computerized and Automated - Rixensart, België - GSK

GSK

Geverifieerd bedrijf

Rixensart, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Site Name:
Belgium-Rixensart

Posted Date:
May

Job Purpose:

As part of the Quality for R&D department, our Clinical Laboratories Quality team is composed of a dozen of experienced and junior staff.

We work in partnership with Clinical Laboratory Sciences (CLS) to provide Quality guidance and oversight to secure effective GSK pipeline delivery and regulatory submission approvals.

We are a growing team with a strong sense of teamworking and exciting projects to come. We would be delighted to welcome you.

Within CLS, your main stakeholders will be the Technology Strategy & Delivery functions. You will also work in partnership with transversal Quality support functions.

In this role you will:

Provide QA expertise and support to CLS teams to ensure fitforpurpose and robust computerized and automated systems and processes supporting clinical development are in place and assure quality oversight to secure the integrity and reliability of the data
Ensure effective pipeline delivery, audits/inspections readiness and regulatory submission approvals
Ensure that the GxP requirements for critical CLS systems are covered and approved. Support GxP decisions/strategies during validation projects
Proactively identify and manage quality and compliance risks and opportunities
Promote best practice sharing and harmonization of processes to assure consistency, high quality, and efficiency
Ensure one voice Quality and efficient connection between QA and CLS

Why you?:

Qualifications & Skills:

Master's degree in Life Sciences or equivalent
10+ years' experience in validation: fundamental steps of the V Cycle, GAMP 5, validation methodologies and related documentation
Relevant experience in Quality in FDA/EU/ICH/PICS regulated environment
Ability to lead under pressure, implement new initiatives to address business and operational challenges in a global multicultural environment
Fluent in English and French, with strong communication, presentation and facilitation skills

Preferred Qualifications & Skills:

In depth knowledge in Quality System requirements and recommendations for CSV area (21 CFR part 11, GAMP) and for Business in Clinical Laboratories (GCLP, GCP, )
Good knowledge of quality and risk management principles and tools
In depth knowledge and expertise of quality systems, such as Deviation/Investigation, Documentation Management, Training, Change Control, CAPA, Product Disposition, Validation
Ability to partner with R&D business:
Courage to challenge where appropriate
Ability to inspire, partner and coach the organization to improve performance
Ability to engage others and operate a fair process in reaching decision
Demonstrated influence and problemsolving skills
Flexible thinking
Li-GSK

_ This job opportunity is a permanent contract __not_
_ opened for relocation. _

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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