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Quality and Risk Manager - Belgium  

Keyrus Biopharma (company)


Posted on : 23 May 2017

Project Description

Job Description
We are looking for a Quality and Risk Manager to reinforce the team of one of our Pharma clients. 

As Quality and Risk Manager, you will have the responsibility to support the Quality Risk Management center implementing process and supporting activities related to quality and risk management. You will work in partnership with the business across the R&D organization. 
You will take in charge, drive and deliver the following activities: 
  • Implementation of support to Business for Quality Control & Management oversight
  • Risk management programs
  • Implementation of process document simplification and governance
  • Check relevance and compliance of training curricula
  • Participate to Audits and inspections
  • Integration and knowledge management of R&D quality matters
  • Review / input into new/updated/draft legislation in collaboration with Regulatory team
  • Collect data, set up reports/dashboard (KPIs, KQI, ...), prepare lessons learned and associated communication
  • Prepare analysis and build up trends to support Knowledge Management and Transverse Quality Forum
  • Oversee vendors (as relevant)   

  • University Scientific Degree, Master or equivalent in Science or Life Science (Pharmacy, Chemistry, Bio Engineer, Biology, Bio Medical Sciences)
  • Qualification in Quality Management or equivalent experience  

Required skills: 
Hard skills : 
  • Design, implementation and delivery of process improvement and educational projects.
  • Knowledge and understanding of R&D Policies and procedures and applicable regulatory requirements
  • Able to simplify complex situations to enable all parties to play their roles in achieving progress.
  • Good understanding of the company's organisation
  • Able to manage workshop and working group, to deliver output
  • Able to manage challenging project and deliver on time with quality
  • Fluent in English, French is highly recommended.  

Soft skills : 
  • Efficient and good time management skills
  • Good team spirit and team player
  • Deliver quality work, on time
  • Work autonomously
  • Good communication, presentations skills and negotiation skills, ability to interface with multiple partners
  • Positive mind-set, able to work in changing and challenging environment
  • Enterprise thinking mind set.
  • Flexible thinking, build on other expertise  

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 
  • Our company 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.  
  • 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, Bio statistics, Medical Writing & Medical Information, Real World evidence services.