QA Group Manager (Gosselies, Belgium – Evry, France)

In order to achieve our challenges, we are looking for a QA Manager

The Quality Assurance Manager is responsible for managing all QA functions, working with cross-departmental leadership to deliver high quality products on schedule. The QA Manager establishes and maintains a quality system to ensure a company’s facilities, equipment, personnel, methods, processes, and procedures conform to both internal guidelines and applicable standards and regulations.

YOUR MISSION:

• Manage different quality certifications for the OncoDNA Group such as ISO 13485, CLIA CAP
• Accountable for maintaining the appropriate certifications, such as CLIA-CAP accreditation and CE marking of products according to the new CE-IVDR procedure
• Prepares product and process quality reports by collecting, analysing, and summarizing information and trends.
• Participate in the daily tasks necessary to maintain an auditable quality management system (document management (Document management, NC, CAPA, change management, monitoring of indicators, internal audits, supplier evaluation, management review, risk review, risk analysis, ensuring that equipment maintenance and qualification of equipment is carried out…)
• Implement and maintain a Quality Management System compliant with the applicable norms & regulations related to the business of the group
• Provide technical leadership and expertise within the field of Quality Assurance related to operations and projects
• Manage a team of Junior QA representatives

YOUR PROFILE

• You hold an University degree in Science, Biology or Engineering
• Experience of at least 10 years in pharmaceutical, bio technology, medical or diagnostic including solid regulatory compliance knowledge (GCP, ISO 13485, CLIA-CAP)
• Sound understanding of local and international regulatory and compliance requirements and ability to interpret, analyse and apply appropriate legislation.

SOFT SKILLS

• Strong organizational agility with ability to successfully operate in a matrix or team environment across multiple locations, countries and regions.
• Ability to successfully handle multiple responsibilities, priorities and tasks
• Ability to manage complex projects on time and within budget.
• Strong written and verbal communication skills in both UK and FR
• Frequent travel between HQ’s (Evry and Gosselies)