Third-Party Manager – Drug Substance & Drug Product

Third-Party management is your passion? Then jump in and be part of the Drug Product Clinical Supply team at Keyrus Life Science!
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Job Description

The Third-Party Manager – Drug Substance & Drug Product is responsible to set-up the collaboration with a Third-Party (TP) and to manage TP used for Drug Substance (Cell Bank, Chromato, Filtration, Centrifugation, etc.) and Drug Product (Formulation, Filling, Visual Inspection, Lyophilization) production activities.

 Key Responsibilities

  • Manage Third-Party qualification in collaboration with Procurement, Quality and Production Experts.
  • Be the business representative in Master Service Agreement and Quality Agreement set-up.
  • Lead TP governance meeting, both internally (Business Partners & Global functions) and externally to ensure a good operational progress.
  • Be accountable and recognized as Central Point of Contact for the relationship with TP/external suppliers.
  • Be accountable for risk management, deviation ownership, change control authoring and coordinating, and knowledge management.
  • In collaboration with the planning team: review demand versus supply, identify potential risks, keep planning informed on operational planning and potential blocking point to ensure pro-active management in term of 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.
  • Drive continuous improvement projects with TP and with internal and external stakeholders in order to strengthen the TP operational activities. If needed, implement new processes to increase service levels and to enhance business performance. 

Profile

  • 5 years of experience in cGMP environment and/or TP management.
  • Demonstrated successful project management skills.
  • University scientific degree or equivalent background.
  • Need of a good background of TP Management.
  • Area of Specialization: Science/Healthcare, cGMP, Supply Chain.
  • QA/Procurement mindset and/or knowledge is an asset.
  • Languages: English proficiency required (verbal and written), French is an asset but not required.
  • Have excellent communication and organizational skills.
  • Good negotiating, networking experience and advance problem-solving skills.
  • Ability to work as well within a matrix environment, balance priorities, and handle multiple tasks.
  • Ability to work in multi-cultural teams, positive team spirit and interpersonal skills.

What we offer

Join a fast-growing team that is the Third-Party Management (TPM) team and be an important point of contact for the Supply Chain department on Keyrus Life Science's studies! You will have the chance to have an active role within the TPM department, collaborating for a well-known pharma firm and still be part of a family-sized company which is Keyrus Life Science.

At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

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 Life Science 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.

Additional information

  • Remote status

    Flexible remote

We usually respond within a week

Or, know someone who would be a perfect fit? Let them know!

Waterloo, Belgium

Drève Richelle 161
1410 Waterloo Directions

Our offices are the place where you are always welcome when you are not working on client's site or from home. Every single person that joins us is met in a personal and unique way.

What is really common to all of us, is the envy to contribute to the improvement of people’s health. Every employee being part of Keyrus Life Science is therefore fully committed to making the world a better place to live.   

With us, you will be part of our family and feel our human approach culture as of Day 1! 

Already working at Keyrus Life Science Belgium?

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