- Location
- Antwerpen, Antwerp
- Workplace
- Hybrid
- Type
- Full-time
- Department
- Administration
- Source
- Pinpoint
Description
Quality Officer
Department: Quality
Employment Type: Permanent - Full Time
Location: Agomab Antwerp
Description
As Agomab advances its clinical-stage pipeline, we are seeking a Quality Officer to join our growing Quality team and report to the Head of Quality. In this hands-on role, you will help maintain and continuously improve our quality management system, take ownership of document control, and provide practical quality support across the organisation.
Key Responsibilities
- Act as a key Quality contact across Agomab, providing timely and pragmatic guidance to colleagues.
- Support the development, implementation and maintenance of the quality management system, including procedures, policies and training.
- Coordinate document control activities and review and approve operational documents from a Quality perspective.
- Facilitate risk management, change control, non-conformance investigations and corrective and preventive actions (CAPAs).
- Plan and conduct internal audits and self-inspections, and support external audits and regulatory inspections.
- Contribute to the preparation and follow-up of management review meetings.
- Support the validation and lifecycle management of electronic systems, including the planning and execution of periodic reviews.
- Champion continuous improvement, quality awareness and a strong culture of compliance throughout the organisation.
Skills, Knowledge and Expertise
- A bachelor’s degree or higher in life sciences or a related discipline.
- At least three years of relevant Quality experience in a biotechnology or pharmaceutical environment.
- Demonstrated knowledge of GMP and/or GCP quality systems, supported by recent training or certification.
- Hands-on experience with electronic quality management systems and their ongoing maintenance.
- A sound understanding of continuous improvement and right-first-time principles.
- The ability to translate quality requirements into practical, phase-appropriate solutions for a growing, early-stage organisation.
- A proactive, hands-on and collaborative approach, with the confidence to guide and support colleagues across functions.
- Strong problem-solving skills, sound judgement and a pragmatic mindset, combined with an unwavering commitment to compliance.
What we offer
- A high-impact role in an ambitious, innovation-driven biotech company.
- Direct involvement in pioneering therapies for unmet medical needs.
- A collaborative, agile and fast-paced environment.
- A role based in Antwerp, Belgium, with remote-working options tailored to your needs.
- Competitive salary and benefits.
Skills
GCPGMPRisk ManagementCompliance