Senior Specialist Drug Substance Transversal

Il y a 4 mois

Rixensart, Belgique GSK Temps plein

**Site Name**: Belgium-Rixensart
**Posted Date**: Sep 3 2024
**Job purpose**:
The Drug Substance Senior specialist transversal Business operations will be responsible for:

- Training Management for the global Drug Substance organization
- Drive the translation of requirements (EHS, Quality, Finance, Knowledge Management & Risk Management) into fit for purpose DS business processes and the implementation and maintenance of the DS business processes
- Support DS Development Operations & Strategy Head in different continuous improvement initiatives aiming to optimize DS ways of working in various areas, and contribute to implementation across the organization
- Interact with multiple stakeholders across different sites and functions of DS organization and non-DS stakeholders
- Interact closely with TRD function strategy & capability leads and Lab Operations organization
- Drug Substance reference person for non project related topics (infrastructure, facilities,...)

**Your responsibilities**:

- You are the trainer Manager for the global Drug Substance organisation in close collaboration with the global and local Drug Substance Managers and the Written Standard Team incl the implementation of Drug Substance training strategy, management of functional and role specific Drug Substance training curricula. Participating to improvement projects for training management.
- You define and implement the Drug Substance document management strategy aligned with Technical R&D best practices. You lead monthly Drug Substance Knowledge Management Core team. Point of contact for Knowledge Management for the Drug Substance organisation.
- You are responsible for Operational Risk and Issue management for the global Drug Substance organisation.
- You translate requirements (Quality, EHS, Procurement,..) into fit for purpose DS processes.
- You collect feedback on DS business processes and tools, identify opportunities for improvement and actively contribute to the implementation and maintenance of agreed DS business processes, tools and improvements.
- You manage the operational EHS and Quality topics for Drug Substance (incl follow up Management Monitoring, DS Position papers, review of relevant SOP, leading DS BE EHS forum, setup of the DS risk universe and L1 audit plan, preparation of and participation to IBM and A&A audits,..)
- You generate relevant Quality, EHS, Finance kpi to support performance discussion/decision making at DS quality, EHS or other relevant meetings.
- You represent Drug Substance in different communities of Practices in areas of responsibilities
- You interact with the Lab Operations team (EHS, facilities,..), Q4RD partner, EHS managers and other non DS stakeholders
- You are the Drug Substance go-to person for non project related operational questions (a.o. facilities, infrastructure).
- Why you?_

**Basic Qualifications**:

- We are looking for professionals with these required skills to achieve our goals:_
- Master in Biological sciences education with project management experience (Biotechnology, Molecular Biology, Bio-engineering, Biomedical experience) And/or Project management, Business management & transformation, operational excellence education with scientific experience.
- At least 4 to 5 years of experience in vaccines, biopharmaceuticals or scientific environment.
- Proven Experience in Pharma R&D environment.
- At least 2 years in a managerial role covering various business aspects.
- Experience in Project management.
- Experience in managing complex processes or multiple processes at the same time
- Good understanding of Biopharma / vaccine development processes and biomanufacturing.
- Proof of Business skills.
- Understanding GSP and GMP practices & requirements.
- Understanding of Quality (a.o; QMS, QA/QC).
- Good knowledge of EHS (Environment, Health & safety).
- Good stakeholder management and excellent communication skills.
- Strong critical thinking & decision making.
- Fluent in spoken and written English/french both scientifically/technically as well as conversational.
- Open minded & collaborative approach.
- Ability to manage complex processes or multiple processes simultaneous
- Ability to drive change.

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, inves

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