R&d Qp Release Senior Manager - Rixensart, België - GSK

GSK

Geverifieerd bedrijf

Rixensart, België

4 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Site Name:
Belgium-Rixensart

Posted Date:
May

R&D QP Release Senior Manager / Qualified Person deputy

In this role you will

Support and backup the nominated QP on a daily basis in all quality issues, QP related matters and QP related activities as needed and in complex situations such as issues and risk taking (LIC, PIRC, Recall, Quality Council, Quality Agreement )
Be a QP deputy and act under the 18IMP license in case of unavailability of the nominated 18IMP QP and is a key contact for Belgium AFMPS GMP Inspectors
Ensure IMP QP certification and release activities in due time in addition to organization of the activities, support and backup, as well as performing traceability and recall activities in the event it is needed
Ensure QP related systems are correctly implemented to support the full alignment and release of clinical materials in compliance with GSK and regulatory requirements (e

a :
GMP release, Reg release, Product Specification)

Ensure and engage for review and effective execution of the Regulatory Submission Building Process (RSBP) and act as liaison between TRD GMP/TRD GMP Quality and GRA for any regulatory related questions (including questions on Change Control/Deviation/PSF)
In his area of responsibilities, ensure critical issues are adequately managed; ensure identification and characterization of the issue, impact evaluation on quality, safety and efficacy of GSK products and potential impact on clinical data as well on GSK business; ensure timely escalation to upper management including remediation plan proposals
Represent QP/QA department positions/opinions views in all meetings related to the area of responsibility (staff meetings, deviations, CAPA, CC followup meetings, )
Is a key spokeperson front line during regulatory inspection
Proactively identify and manage potential quality and business risks
Educate and influence by his behavior compliance to good quality practices

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

_ Why you? _

Qualifications & Skills:

A proven experience in the Pharmaceutical/Biotech industry with significant experience of GMP within a major authority jurisdiction (EMA/FDA)
Deep understanding of the framework within which a pharmaceutical product has to be developed, registered and launched, Deep understanding of R&D and clinical environment
Indepth knowledge and understanding of international legislation and regulatory standards
French speaker while being fluent in spoken and written English
Expertise recognized in several fields related to release system

Preferred Skills:

Ability to make independent decisions even under pressure
Strong interpersonal skills with demonstrated ability to engage, empower and influence people
Ability to evaluate product compliance and quality issues and make sound recommendations regarding problem resolution
Ability to communicate complex information both orally and in writing
Ability to listen effectively
Ability to drive change

#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 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.

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.

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.