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.
Key Responsibilities
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.
Skills, Knowledge And Expertise
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.
Benefits
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.
Seniority level
Not Applicable
Employment type
Full-time
Job function
Quality Assurance
Industries
Biotechnology Research
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