Flen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device markets. We have a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA.
At Flen Health, we focus on people with topical inflammatory and infectious diseases. Our vision is to shape a world, where wounds and skin disorders do not stop patients from living the life they love by developing innovative technologies and distributing them across the globe.
At Flen Health, we expect you to show grit, to take ownership of your initiatives, to go for it and we guarantee that you will then appreciate the result of your work, whether individually, as a team or companywide. As an intrapreneur, you will enjoy working in a multicultural diverse environment where trust and open communication are key, and where a positive can-do attitude drives sustainable growth. We offer a flexible working ecosystem, enthusiastic colleagues, and an attractive remuneration package.
We are looking for a Quality System & Governance Senior Specialist for an immediate start to reinforce the Quality department and this role will report directly to the Quality & Regulatory Compliance Director. This is a permanent full-time position based in our Belgium office, in Kontich.
As Quality System & Governance Senior Specialist, you ensure a robust, consistent and audit-ready Quality Management System by governing the QMS framework, management review process, internal audit system and QA training structure across the organization. This role acts as the central governance owner of the QMS, ensuring alignment between operational Quality, Regulatory Affairs, Design & Development Quality and Lifecycle Quality.
This position will suit you perfectly if you have a taste for challenges and the desire to make things happen!
Your responsibilities:
QMS Governance:
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Own and maintain the overall QMS framework and structure
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Ensure consistency of SOP hierarchy, governance principles and document lifecycle
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Ensure the QMS remains compliant with applicable regulations and standards
Management Review:
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Own the Management Review process
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Define agenda structure, required inputs and reporting format
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Consolidate quality system KPIs and governance metrics
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Ensure follow-up and closure tracking of management review actions
Internal Audit Governance:
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Own the internal audit program and annual audit planning
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Ensure audit readiness across functions
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Coordinate audit follow-up and effectiveness tracking
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Support external audits and inspections from a governance perspective
QA Training Governance:
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Own the Quality training framework and training matrix governance
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Define training effectiveness expectations
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Ensure alignment between process ownership and training execution
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Coordinate annual Quality training planning
QMS Oversight & Continuous Improvement:
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Monitor QMS health indicators and governance risks
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Identify systemic gaps and improvement opportunities
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Support harmonization and simplification of quality processes
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Ensure governance alignment between QA D&D, QA LCM and RA/QA functions
Your qualifications & experience:
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You are graduated (Master’s degree) in Pharmaceutical Science or in Science or equivalent based on relevant experience
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You demonstrate at least 5 years of successful working experience in a medical device quality department
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You have experience with quality processes and procedures
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You possess strong experience with at least ISO 13485 and MDR (Medical Device Regulation)
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You have in-depth knowledge of other Regulatory applicable regulations in the medical device and/or pharma industry
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You have proven competence as an (internal) auditor
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You know good documentation practices and have some GxP experience
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You have analytical thinking & problem-solving capability
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You are proficient in MS Office
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You have QMS software knowledge
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You have good knowledge/experience in semi-solids manufacturing and Quality Control
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MDSAP experience would be considered as an asset
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You are fluent in English, oral and written. Other languages such as Dutch, German or French are an asset
What we offer:
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Excellent working conditions
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An innovative and inspiring international work environment
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Independent project work & responsibilities within a professional team
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Career prospect
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Learning and development opportunities
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Competitive remuneration according to experience
