Senior Manager Incoming Materials Technical Life Cycle Management
Stiefel Laboratories, Inc
Wavre, Belgium
6 dagen geleden

Your Responsibilities :

  • The present approved GSK vaccine portfolio includes around 55 different products and around 10.000 incoming materials (IM).
  • This portfolio needs continuous process and product maintenance in order to keep the products in a compliant state at all times.

    The MSAT Technical Life Cycle Management department focuses on the technical aspects linked to Processes, Incoming Materials and Products.

  • The Senior IM TLCM Leader is responsible to lead and animate complex multidisciplinary IM Technical Life Cycle Team (TLCT).
  • IM TLCTs are central point of a federated Incoming Material (IM) Operating Model, bundling all IM expertise following principles defined within the IM Development & Life Cycle community (part of the IM Model) with the mission to build fit for purpose IM specifications, qualify robust suppliers and IM’s to ensure quality, supply continuity in production, minimizing changes and costs

  • The Senior TLCM Leader ensures the establishment and maintenance of Process, Incoming Materials and Product knowledge and the preparation of a risk / opportunity map to withdraw continuous improvement projects.
  • The Project Manager TLCM prepares the continuous improvement projects including business cases, prepares the required budgets, and ensures the project management according to GSK Vaccines standards in an efficient, timely and cost-efficient way.

  • The Senior IM TLCM ensures continuous exchange of knowledge between the different manufacturing units / sites, QA, QC, RA, GSCM, R&D, Engineering, MSAT TLCM Product & Processes and other MSAT entities, Procurement, IM Supply & IM Strategy teams and with external experts ( Suppliers, Universities, Professional associations .)
  • Key Responsibilities :

  • The Senior TLCT Leader is responsible to lead and animate complex multidisciplinary Technical Life Cycle Team (TLCT). Each Senior TLCT Leader is responsible for specific Incoming Materials clusters ( Chemicals & Biologicals / Testing & Environment / Filtration Chromato & Critical Spare Parts / Single Use Systems & Bioprocess Containers / Secondary Packaging & Cold Chain / Primary Packaging / Innovation & New IM creation )
  • The Senior TLCT leader acts as a guardian, ensuring an harmonized and efficient way of working for the core processes linked to End to End IM Life Cycle Management across GSK Vaccines.
  • S)He is responsible to ensure that projects are executed using the e-Change Control process in the most efficient way as a GMP tool (Phase 0, cc Boards, etc. )

  • The Senior TLCT leader ensures a proactive management of our Incoming Materials by selecting, shaping and implementing the IM Projects that will bring most value to the company (integration of the costs via adequate Business Case, quality, lead time and total cost of Ownership TCO).
  • The TLCT Leader ensures that his / her TLCT is the single point of contact for the different manufacturing units / sites, QA, QC, R&D, TLCM P&P franchises and RA with regard to IM Development & Life Cycle matters.
  • The Senior TLCT leader ensures that his / her TLCT team is the referent for a domain of technical expertise. (S)he keeps (her)his knowledge up to date with the current developments of the related technologies by performing technology watch activities.

  • The Senior TLCT Leader is responsible to develop a Strategic Agenda integrating procurement, quality and technological dimensions and is responsible that projects are executed in line with the Strategic Agenda of the IM TLCT endorsed at the IM council and is responsible to report and present they progression at the governing bodies overseeing the MSAT TLCM and the IM Model (IM Development & Life Cycle, IM Supply, IM Strategy, IM council ).
  • The Senior TLCT Leader is responsible to feed and maintain the knowledge management for the IM Cluster in his / her field of responsibility and to ensure continuous exchange and update of the production units / sites, QA, QC, RA, GSCM, OE, COE, Engineering , R&D , MSAT entities respectively.
  • The Senior TLCT Leader is responsible to prepare, maintain and execute a risk heat map & mitigation action log for Incoming Materials in his / her field of responsibility.
  • Within her / his domain of technical expertise, the Senior TLCT leader supports or leads troubleshooting during complex issues, provides expertise for the contact with authorities and is able to train people acting as a mentor and coach
  • The Senior TLCT leader is responsible to handle the TLCM relationship management activities for one or more suppliers (according to the defined SRM Roles & Responsibilities).
  • At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

    If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements you will have the opportunity to let us know what specific assistance you require.

    This will help us to make suitable arrangements to support you throughout our selection process.

    Basic qualifications :

  • Advanced degree in process engineering sciences, and / or academic level in life sciences in general.
  • Area of Specialization : Life Sciences
  • Minimum 12 years applicable experience in biopharmaceutical manufacturing and / or experience in QA, QC, RA or GSCM within a biological environment
  • Experience in project management including management of people from very different environments (cf current job description)
  • Excellent understanding of the framework within which a pharmaceutical product has to be maintained in compliance : Authorities / Scientific / Business
  • Preferred qualifications :

  • At least Master degree
  • Area of Specialisation : GMP, RA, Production, QA, QC, Engineering, Procurement or Supply Chain Management.
  • Proven Track record in problem solving and global project management
  • Proven ability to plan, manage and lead cross-functional teams and projects to obtain desired business objectives
  • Proven ability to communicate and negotiate effectively with all levels of management across functional, national and cultural boundaries
  • Proven ability of understanding compliance requirements
  • Excellent interpersonal communication and negotiation skills
  • Trans-cultural experience and proven ability to work in a complex and multi-cultural environment
  • Proven Matrix Management skills
  • Excellent in Data analysis and IT tools
  • Excellent skills in project management, change management and team / meeting facilitation
  • Leadership / people and relationship management
  • Proven track record in leading cross-functional teams
  • In addition, demonstrated competency in the following areas is required :
  • o Analytical, influencing, negotiation and problem-solving skills

    o Business integration capabilities to translate internal and external best practices

    o Process re-engineering

    o Conflict resolution and consensus building

    o Understanding of business climate and priorities

    Why GSK? :

    GSK is a science-led global healthcare company with a special purpose : to help people do more, feel better, live longer.

    We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.

    Vaccines Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

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