Functie

We are looking for a Quality Manager to expand our Quality team, reporting to the Head of Quality. Ideally, you have experience with GMP and/or GCP quality standards. Experience with other quality standards like G(C)LP and/or GDP is a pre. The role will require operational expertise, and you will be responsible for the management of the quality management system and for qualifying and overseeing our vendors.

What will you do?

• You are a primary point of contact for Quality for the Agomab organization. You participate in the different project teams and provide the quality support;
• Develop and Maintain quality system including the writing and maintenance of procedures and policies, setting up training, performing internal audits & self-inspection;
• Participate in selection of vendors. Determine the qualification strategy for these vendors;
• Independently perform audits of vendors. Maintain quality oversight of vendors and performance monitoring;
• Guide the teams in Change Control, Non-Conformance and CAPA system;
• Participate in audits and regulatory inspections;
• Quality review and approval of operational documents;
• Set-up and participate in management review meetings.

Jouw profiel

• You have as a minimum 5 years’ experience in a similar role in a Biotech/Pharma company;
• You have a BSc or higher academic degree in a relevant area;
• You have proven track record in GMP and or GCP quality systems;
• You are a trained vendor auditor;
• You have an hands-on approach in a start-up culture;
• You understand the requirements of a growing early phase development Biotech/Pharma company and you can provide phase appropriate solutions;
• You have experience in selection and implementing (including validation) of electronic quality systems;
• You are entrepreneurial and creative but with a high sense of compliance;
• You are a quality leader, guiding and supporting the teams;
• You are flexible, can travel when needed.

• Het werk van leveranciers of dienstverleners controleren
• Domein: Continue verbetering
• Kwaliteitsgegevens opvolgen en analyseren
  Veranderingen en verbeteringen bepalen
• Documentatiemateriaal voorzien, beheren en actueel houden
• Kwaliteitsprocedures uitwerken en aanpassen en de correcte toepassing controleren
• Het plan, de fases en de acties van kwaliteitsopvolging ontwikkelen en uitvoeren
• Domein: Kwaliteitsmanagementsysteem
• De personeelsleden bewustmaken van en opleiding geven over de benadering van kwaliteit
• Domein: Kwaliteitscontrole
• Gevallen van non-conformiteit analyseren
  Corrigerende acties bepalen en aanbevelen

Aanbod

What we offer

• The opportunity to develop pioneering science in a young biotech company;
• Challenging and innovative work environment as part of a driven team;
• Flexibility and responsibility with office based in Antwerp Belgium and remote working options that can be tailored for you;
• Competitive salary and benefits;
• An agile and fast paced environment.

Solliciteren

Mirjam Bollema
+32 3 302 35 30
mirjam.bollema@agomab.com