Job Description

Keyrus Life Science is looking for a Clinical Process Expert to join our team based in Waterloo, Belgium! 

The Clinical Project Expert is accountable for the design and implementation of systems and processes within the R&D manufacturing and Clinical Supply activities. This includes continuous improvement of the manufacturing & clinical supply processes, systems, facilities and technologies.

In this role you would:

• Lead key projects within the R&D Manufacturing & Clinical Supply, as assigned; this includes all prioritized projects, such as strategic needs, facility improvements, product, system and process projects.
• Support Manufacturing and Clinical supply management through documentation, process review, authoring; change control generation/closure; Standard Operating Procedures review, etc. to ensure the success introduction of new/improved products and processes as needed. Interact with all stakeholders inside and outside of the organization.
• Work across R&D Manufacturing and external stakeholders (e.g. clinical) to deliver systems (Standard Operating Procedures) which directly support Development, Phase I, II and III Clinical Manufacturing and clinical study activities in an efficient, flexible and compliant manner.
• Implement and manage the KPI strategy for the department, which will track and report on quality, performance and personnel metrics; proactively use these KPI’s to prevent issues, continuously improve the business, and communicate needs to leadership.
• Support manufacturing and clinical supplies, supervision, management, etc., as needed to cover departmental priorities.
• Support the risk management process and own remediation plans.

Profile

• Must-have: certification in Project Management (Prince 2, Lean Six Sigma or Green Belt) OR minimum 5 years of experience in Clinical Project Management (GMP/GCP pharmaceutical environment).
  
• Master's degree in Management, Economy, Logistics/Supply or Sciences.
• You are a process-oriented thinker who succeeds in communicating his/her analyses clearly and convincingly.
• You are curious, proactive, and consider yourself as a driver for the project you are involved into.
• You are a team player with strong interpersonal skill.
• Fluency in written and spoken English is required. French is an asset.

What we offer

A unique fast-paced environment in transformation, a unique project to lead, facilitate and support dozen of initiatives to bring process optimization in our Clinical supply department.

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 skilfully, 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.