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Global qa/ra director

KEY 4 Nova Bv
Publiée le 24 novembre
Description de l'offre

Our client is a global leader in clinical and commercial packaging solutions for the pharmaceutical and biotech industry. With state-of-the-art facilities and a strong reputation for quality, innovation, and compliance, the company supports customers throughout the full product lifecycle—from design to delivery. To strengthen its global Quality organization, we are recruiting a: Global QA/RA Director As Global QA/RA Director, you will: Report directly to the SVP Global Quality (dotted line to the SVP & Managing Director Clinical & Europe). Be an active member of both the European Commercial Management Team and the Global Clinical Leadership Team. Lead and coach QA Heads and sub-functions across four international sites. Define, harmonize, and implement global quality policies, standards and procedures, aligned with cGMP, internal requirements, and client expectations. Champion a solid Quality Culture across clinical, packaging and operational activities. Collaborate cross-functionally with Technical, Operations, Engineering, Business Development and Supply Chain. Oversee the Pharmaceutical Quality System (PQS) and drive continuous improvement. Optimize quality systems, clarify roles and structure of local QA teams. Supervise batch record review, validation activities (equipment, cleaning, CSV), and key compliance processes. Lead audits (client, supplier, agency) and manage regulatory filings as needed. Handle customer escalations and lead global management review processes. Stay up to date with regulatory trends and represent the company toward health authorities, clients, and suppliers. Manage the quality budget and contribute to strategic planning at global level. Travel across Europe and th e US when required. Master's degree minimum, ideally in Pharmacy, Life Sciences or related field. Additional certifications in QA/RA or GxP are a strong asset. 15 years experience in senior QA/RA roles in the pharmaceutical sector. Proven track record managing international, multi-site quality teams. Deep knowledge of GxP, quality systems, validation and regulatory requirements. Fluent in English (Dutch is an asset). Strategic mindset with strong operational leadership and hands-on spirit. Excellent communication, influencing and change management skills. Willingness to travel internationally. A technical and modern environment with a strong focus on quality and innovation. The Global Quality, Multi Site, Management Review, Communication, Team Leadership, Management, Strategic Planning, Health System, Practicality, Lead audit, Stay Informed, Management, Quality systems, Asset, Validation, Supply chain, Budget, Customer Escalation, Pharmaceuticals, Policy, Quality systems, Engineering, Batch Record Review, Document management, Leadership, Cross Functionality, cGMP, Life Science, Process Review, Operations, Packaging, Quality assurance, GxP, Regulatory Filing, Change Management, Pharmacy Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be! Original job ad is published on StepStone.be - Set up a Jobagent at StepStone now and find your dream job! https://bit.ly/2jPYsZC For similar jobs, information on employers and career tips visit StepStone.be! La version originale de cette offre d'emploi est disponible sur stepstone.be – Créez maintenant votre Job Agent sur StepStone et trouvez le job de vos rêves ! https://bit.ly/2jPYsZC Trouvez des jobs similaires, des informations sur les employeurs qui recrutent et des conseils de carrière sur stepstone.be!

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