Quality Manager
Functieomschrijving
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.
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.
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.
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