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Belgium Keyrus Life Science

Third Party Manager – Drug Product

Job Description

The Third-Party Manager Support is responsible to set-up the collaboration with a Third-Party (TP) and to manage TP used by GSK Vaccines for Drug Product production activities (Formulation, Filling, Visual Inspection, Lyophilization).

Key Responsibilities:

  • Manage project of TP selection based on defined criteria (technical and business performance and capacity, quality, cost, etc.)
  • Establish processes to start the collaboration with the selected TP (Master Service Agreement, pilot phases, planification, etc.)
  • Be accountable and recognized as Central Point of Contact for the relationship with TP/external suppliers
  • Be accountable for technical management including risk management, deviation ownership, change control authoring and coordinating, and knowledge management.
  • Be the partner of peers and stakeholders in their department, GSK internal network to share vision and work towards common objectives, promoting enterprise thinking
  • Participate in all meetings that are part of the TP governance, both internally (Business Partners & Global functions) and with the external suppliers, to ensure a good operational progress
  • In collaboration with the planning team: review demand versus supply, identify potential risks, keep planning informed on operational planning and potential blocking point
  • Ensure visibility is given on demand and supply information across the supply chain to ensure pro-active management, ensure the supply chain (capacity, technical feasibility, etc.)
  • Be responsible for performance management and reporting (KPI, monthly)
  • Interact with QA team to ensure compliance of the external operations with cGMP
  • Proactive view on critical risks and ownership of mitigation defined
  • Drive continuous improvement projects with TP and with internal and external stakeholders in order to strengthen the TP operational activities. Implement new processes to increase service levels and to enhance business performance

Profile

Educational background

Minimum/Preferred Level of Education:

  • University scientific degree or equivalent background
  • Area of Specialization: Science/Healthcare, cGMP Manufacturing and Supply Chain
  • Need of a good background of Drug Product production & TP Management
  • QA/Procurement mindset and/or knowledge is an asset

Job-Related Experience

Level of Job-Related Experience required

  • 5 years of experience in Clinical Study Supply Chain and/or GMP environment and/or TP management
  • The Third-Party Manager – DP needs to have a clear view and understanding on the requirements for Drug Product production

Other Job-Related Skills/Background

  • Relevant project management experience
  • Relevant Drug Product production experience
  • Demonstrated successful project management skills
  • Languages: English proficiency required (verbal and written), French is an asset but not required
  • Have excellent communications, organization, investigation and negotiation skills, be diplomatic able to establish priorities and develop and implement new procedures when needed as well as predisposition to quality management, project management and process improvement
  • Good negotiating, networking experience and advance problem-solving skills
  • Demonstrates ability for leading initiatives with cross functional teams and implementation of recommendations
  • Ability to work as well within a matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organization skills
  • Effective ability to prioritize tasks and deliver on deadlines, with high performance standards and a commitment to excellence
  • Ability to work in multi-cultural teams, positive team spirit and interpersonal skills
  • Is self-driven by successful execution of different tasks
  • High level of flexibility and sense of urgency
  • Operates with a high degree of integrity, responsibility, independence and initiative

What we offer

You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…). Each employee will be welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

Keyrus Belgium Offices:

  • Office Park Waterloo - Drève Richelle 161 - 1410 Waterloo
  • Nijverheidslaan 3, - Strombeek-Bever

Category

Manufacturing/supply chain

Location

Walloon Brabant

Contact person

van Strien