Regional Quality Assurance Manager(RQA Manager)

Job Purpose:
BU Regional Quality Manager will ‘own’ the Quality System as a Head Office function, the general day to day administration of the system is carried out by the nominated QA/QC person that are in the RQA Managers perimeter. In this position there will be some quality testing for our customers and Business unit in our lab in Peruwelz. This test will be worked out together with colleges, GMP/Operations Director or Innovation Manager
Using recognised continuous improvement / lean manufacturing methods your objective will be to support a cultural change programme where Quality is embraced by people and achieve a ‘best in class / best practice’ ethic as to deliver consistent operational excellence across all plants in the perimeter.
• Support critical customer audits and help set local internal agenda
• Provide regulatory monitoring and act as knowledge centre for local QA/QC coordinators
• Assist plants in providing yearly risk and quality analyses
• Support in set up validation protocols
• Running tests in Test lab for customers
• Support cleanroom wide new product introduction
• Support in building up and updating “knowledge sharepoint” for best practice and education program
You will work closely with the plant management & their teams offering guidance and support and will mean often traveling to other sites.

KPI’s:
• Secure quality and reliability on data for the production unit
o Quality standards are met
o Agreed batch documentation is available
o Audit findings are being handled and solve
• Report and interfere on deviations on KPI targets
• Customer satisfaction
• Complaint reporting
Role & Responsibilities:
• Devise procedures to inspect and report quality issues
• Monitor all operations that affect quality
• Supervise, train and guide QA/QC, technicians, production management and other staff
• Assure the reliability and consistency of production by checking processes and final output
• Appraise customers’ requirements and make sure they are satisfied
• Report all malfunctions to site management and GMP/Operations Director to ensure immediate action
• Facilitate proactive solutions by collecting and analyzing quality data
• Review current standards and policies
• Keep records of quality reports, statistical reviews and relevant documentation
• Communicate with external quality assurance officers during on-site inspection
• Organize meetings and seminars for internal auditors as needed.
• Ensuring the necessary competences regarding the management system in the organization.
• Acts as Lead Auditor in the internal audit team.
• Support Innovation development with test, reports, validations etc.
Knowledge and Skills:
• Instil respect in the organization
• Thorough knowledge of the ISO Quality Standard – design, implementation, audit and compliance.
• Knowledge of Continuous improvement/Lean methodologies such as; Six Sigma, 8D, Kaizen etc.
• Good IT skills
• Experience of supporting multiple sites or other tasks that involve travel.
• Proven experience as a quality assurance manager or relevant role
• Thorough knowledge of methodologies of quality assurance and standards
• Good numerical skills and understanding of data analysis/statistical methods
• Good knowledge of MS Office
• Good communication skills
• Great attention to detail and a result driven approach
• Reliable and Trustworthy
• BSc/BA in business administration or relevant field
• Certification of quality control is a strong advantage (ISO 9001 etc.)
• Language French, English is needed and Dutch is preferred.
Education/Experience:
• A bachelor's degree in an industry-related field and minimum of 4-5 years of experience in the field or within life sciences market
• Must be aware of international variances in cultural and legal issues.
• Familiar with a variety of the field's concepts, practices, and procedures.