Quality and compliance manager
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Brussel Belgium.
You will work at a company with a high purpose. They believe all people deserve to live healthy lives. This drives their desire to provide access to medicines that are safe, effective, and affordable.
ROLE DESCRIPTION
In the role as Quality and Compliance Manager (QCM) you are dedicated to Inspection Readiness and Continuous Improvement. You will deliver and execute the quality program at their company. You will interact with a different stakeholders and subgroups on high level. Are you ready for a next step where you will have lots of responsibilities and influence? Are you ready for some complex projects where you can put all your energy in? Do you have great communication skills with all kinds of departments internally and externally ? Then this is the perfect job for you!
RESPONSIBILITIES
You will be responsible for Good Clinical Practices oversight and for assuring compliance projects and programs with SOP's, Policies and all applicable worldwide regulations and guidelines.
This position is responsible for internal quality and compliance reviews and for the communication and report out of such activities (compiling observations) including any follow up needed (CAPA completion). The following topics will be within you responsibilities:
- Quality Management System
- Quality Performance Analytics
- Procedures
- Inspection/Audits
- Compliance
- Training
- Efficiency
- Organizational Relationships
REQUIREMENTS
A scientific or technical degree (MS or BS), with 5 years experience in a similar role
Experience with SOP and training implementation
Experience conducting, managing or participating in regulatory inspection processes
Experience with inspection readiness
Experience managing complex projects
Comprehensive knowledge of ICH-GCP practice
A strong working knowledge and understanding of drug development processes
Certification in Lean Six Sigma tools and methodologies is a clear asset
Fluent in English and in French and/or Dutch
Strong communication skills
Strong project management skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Valentijn de Krom.
