Quality Compliance Officer - Mechelen
|Publication date:||November 13 2019|
Do you want to work at the world’s leading inspection, verification, testing, and certification company? This organisation is the worldwide benchmark for quality and integrity! They owe this reputation to almost 100.000 employees working at approximately 2500 offices and laboratories. The core values of this organisation are passion, integrity, entrepreneurship and innovative spirit. These values form the guideline for everything they do and form the foundation on which the organisation is built. In Belgium there are almost 2000 employees and the office in Mechelen is looking for expansion in their life science division.
The Quality Assurance Department is an independent department of the Clinical Research department within the Life Science Division. It is responsible for the Quality Management System. This system covers quality documents, training and qualification, resolution and documentation of deviations, auditing activities, and dedicated quality support to all departments. The objective is to protect the safety and wellbeing of clinical trial subjects and reliability of trial data through adherence to ‘Good Clinical Practice’ and other relevant international quality standards (GxP), applicable regulatory requirements for Clinical Research, and internal procedures. Within this department, we are looking for a Quality Compliance Officer.
As the Quality Compliance Officer, you ensure the effectiveness of the organisation’s Quality Management System for an assigned area of operations. You will report to the Director Quality. Your responsibilities include but are not limited to:
- Trying to always meet the agreed timelines and quality objectives. Therefore, you collaborate closely with the assigned areas of operation in order to ensure the development and maintenance of effective quality documents
- Furthermore, you liaise with other areas/departments for cross-functional topics to be addressed and created accordingly
- Being the ‘single point of contact’ for auditors and regulatory inspectors. This means you facilitate and follow up on client audits and regulatory inspections, always in close collaboration with the QA assistant.
- You also provide leadership and training to operations colleagues in case of these audits and inspections
- Being the ‘light in the dark’, you guide the responsible persons in performing adequate Root Cause Analysis. You help them with defining and implementing adequate and compliant Corrective Action and Preventive Action (CAPA) Plans for reported deviations
- Analysing and discussing trends in reported deviations and their impact. When needed you will report to the senior management
- Interpreting new or updated regulations and guidelines, policies, and procedures as necessary and provide interpretation and consultation to your colleagues regarding these topics
- Carrying out the ‘culture of quality’. When process improvement opportunities present themselves in both the operations or QA area, you identify and promote them. You develop training materials and/or deliver training to assure quality awareness all around
- You have obtained a university degree in sciences, a (para)medical area or pharmaceutical sciences. An equally recognised degree and/or relevant qualifications by experience may also be acceptable and will be evaluated on a case-by-case basis
- You have a ‘track-record’ of at least eight years’ experience in a university research department, laboratory, or pharmaceutical, biotech, medical devices or a similar company. Or a CRO or equivalent combination of education, training and experience
- You have strong project management and people management skills in a matrix environment
- Your knowledge of English is as close to ‘mother tongue’ as possible, this in written as well as spoken. Knowledge of other languages is a plus
- You possess excellent communications skills
- You can handle several complex projects or initiatives simultaneously
- What is a team without a team player? You love to work in a team and can handle stress like a pro, thanks to your well-organised competences
- You are a responsible and integer person with a real quality mindset and a big interest for customers; your sense of diplomacy and confidentiality is very high
- You have a strong affinity with (inter)national guidelines and regulations related to clinical research and the ability to make decisions based on appropriate interpretations
- If you have already some experience with an electronic document management system, then this is a big plus, since one of your responsibilities will also include the management oversight of the electronic document management system and the reviewing of the work of the QMS administrator
- An interesting position with many responsibilities
- An annual salary between €65,000,- and €85,000,-
- Company car
- Pension scheme / Retirement plan
- Meal vouchers
- Good insurances
- Expenses account
- Fun team of colleagues
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Sr Consultant Biotech/Pharma