NA NA Gent Belgium
The company offers genomic and transcriptomic services, performed in an ISO accredited lab, to support research, clinical trials and personalized medicine. Their customers rely on our expertise in RNA biomarker discovery, development and validation, their pioneering role in liquid biopsies and non-coding RNA, and their experience with clinical trials to accelerate the development of their diagnostics and therapeutics. Our service portfolio is built on state-of-the-art technologies such as RNA sequencing, high-throughput qPCR and digital PCR, all combined with advanced data analysis methods.
The QA/RA manager coordinates the maintenance of the quality management system and is responsible for implementing and operating the quality management system on a day to day basis. In addition, the QA/RA manager needs to assure that all services are delivered in line with appropriate legislation and quality standards.
QA related tasks include:
Ensure that all processes involved in the quality management system are defined, documented implemented and comply with the ISO/IEC 17025 international standard and GCLP guidelines. Ensure that documents are maintained and revised continuously.
Develops and maintains the latest versions of the quality handbook. Makes sure that the quality handbook complies with the ISO/IEC 17025 norm and GCLP guidelines.
Define, document and implement new procedures when needed
Coordinating the company’s document management system.
Manage all employees and co-workers to ensure correct implementation (and follow up of all procedures) of the quality management system. Makes sure that the quality objectives, set by the management (quality policy) are in the focus of the organization. Coaches the relevant people in understanding them and obtaining them.
Yearly set up and follow up of the quality calendar.
Perform internal audits and prepare and host external audits.
Identify relevant quality-related training needs and organize trainings
follow up on complaints, nonconformities & deviations, and actions from audits and monitor the effectiveness of the corrective and/or preventive action taken. Coordinate and implement the defined action plans according to the set time lines.
Ensure the further maturation of the quality management system
Support in method, software and instrument validation
Inform the company's top management about the status of the quality management system (goals, KPIs, etc).
Prepare management review meeting and ensure that this management meeting is carried out in accordance with the quality calendar. Makes minutes and action plan out of this meeting and communicates this together with the management to the organization.
Support project managers and sales team in answering QMS-related questions coming from customers.
RA related tasks include:
Studying scientific and legal documents
Keep track of ever-changing legislations (Belgium and abroad) that are relevant for the services delivered to our customers
Formulate and implement regulatory affairs policies (including GDPR and biobank legislation) and procedures to ensure that regulatory compliance is maintained or enhanced.
Provide regulatory guidance regarding design, development and implementation of biomarker assays in clinical trials
Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes
The QA/RA manager reports to the management
Requested competences and skills:
Experience in QA and SOP management is required.
Must be able to understand, interpret and implement quality standards and regulatory guidelines.
Affinity with lab management, molecular biology techniques and general lab techniques is an asset.
Process understanding in lab environment.
Good project management skills.
Strong affinity to quality control.
People coordinating and coaching skills, knowing how to motivate people according to project time lines.
Must be able to interact in a professional manner with employees and all levels of management.
Excellent oral communication, reporting and presentation skills.
Ability to work independently as well as a member of a team.
Able to identify problematic situations, to communicate appropriately, to initiate problem solving processes and to propose remedial actions.
Analytical and critical mindset.
Able to digest literature on quality management and understands the scientific touch of the methods used.
Strong in administration.
Focused to ‘quality thinking’.
People management skills.