Flen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device technological domain. Flen Health has 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 are convinced that we do help people live the life they love through developing innovative technologies and bringing these to patients across the globe. We focus on patients with topical inflammatory and infectious diseases.
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 company wide as Flen Health. 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 eco-system, enthusiastic colleagues, and an attractive remuneration package.
We are looking for a Quality Assurance Director for an immediate start. This is a permanent full-time position which can be based in one of our 6 entities (LU-BE-NL-DE-UK-IRE), reporting directly to the Vice-President R&D, Quality Assurance and Regulatory Affairs.
As head of the quality department, you will lead and transform the operational performance of the team, ensuring the successful delivery of quality objectives, whilst adhering to regulatory compliance and achieving commercial success. As a highly analytical and meticulous professional, monitor the implementation of the e-QMS to comply with the ISO13485:2016, 21CFR 820 and regulatory requirements for Medical Devices.
This is a leadership position, responsible for building a team and a fantastic opportunity to join an innovative and dynamic wound healing company with a fantastic development pipeline.
What we offer:
- Excellent working conditions
- An innovative and inspiring work environment
- Independent project work & responsibilities within a professional team
- Career prospect
- Learning and development opportunities
- Competitive remuneration according to experience
- You oversee the Quality Management System performance and drive continuous improvement for both compliance to ISO 13485 & 21CFR 820 and applicable Medical Device regulations and GxP
- You are responsible for all Quality documentation and reports
- You develop and implement quality strategies including global strategies that ensure procedures and policies meet applicable standards and regulations
- You drive and lead quality project meetings
- You report to the Vice-President R&D, Quality Assurance and Regulatory Affairs on the performance of the Quality Management System and give input during management reviews on any need for improvement
- You provide support to the Vice-President R&D, Quality Assurance and Regulatory Affairs in the company-wide innovation management processes, including projects outside the direct scope of the function
- You monitor Quality control of clients and suppliers to guarantee their contribution to the quality of the Flen Health products and services
- You drive and implement Quality awareness programs throughout the company
- You communicate with certified/notified body and official institutions concerning quality management system issues, audits, inspections and changes You drive and lead quality project meetings
- You are responsible to drive Risk management, both product and business oriented
- You lead quality Inspections from Authorities and audits from Flen Health customers
- You monitor performance of the audit program: both internal audits as well as external audits at suppliers/subcontractors
- You work in close cooperation with Internal departments to ensure QMS alignment concerning submissions, design dossiers, technical files, and other regulatory and R&D documents
- You setup and follow up of departmental objectives and budget
Your qualifications & experience:
- You hold a degree (Bachelor/Master) in Pharmaceutical Science, in Science or equivalent based on relevant experience
- You can justify a solid professional experience in the management of a quality department and in team and project leadership
- You are fluent both written and spoken in English, other languages as Dutch, French or German are an asset
- You hold perfect command of quality processes and procedures, and your strength is your keen eye for detail
- You have knowledge or experience in internal auditing
- You demonstrate an analytical thinking & problem-solving capability
- You are experienced in product manufacturing and GxP
- You are proficient in MS Office
- You have strong knowledge of:
- ISO13485 and 21 CFR 820
- Medical Device regulation
- QMS software
- You have an ISO/EN auditor certificate or the desire to obtain it
- An experience of semi-solids manufacturing and/ or Quality Control is an asset
Are you interested in working with an ambitious and very dedicated team?
Please send your application, CV and motivation letter to the following email address: firstname.lastname@example.org