Job description
Mission Overview
Lead quality assurance oversight for the implementation of automated and computerized systems within clinical laboratories and central scientific teams. Ensure compliance with global regulatory standards and internal quality systems to support pipeline delivery, audit readiness, and regulatory submissions.
Key Objectives of the Role
* Guarantee that business processes, equipment, and analytical/automated systems are developed, qualified, and validated in compliance with GCLP, GCP, ISO 9001:2015, and internal quality requirements.
* Serve as a key QA partner to cross-functional teams, providing expert guidance throughout the automation lifecycle.
* Promote a unified quality approach (“one voice quality”) across projects and departments.
* Review and approve critical quality documentation related to CSV, GCLP, and GCP activities.
* Support resolution and escalation of complex technical and compliance issues in line with company procedures.
Key Responsibilities
* Lead QA oversight for computerized systems validation (CSV) and equipment qualification across lab and automation projects.
* Review and approve validation deliverables (e.g., URS, FDS, IQ/OQ/PQ protocols, validation reports) from a quality perspective.
* Act as a quality advisor to project teams, ensuring integration of quality principles from design to decommissioning.
* Facilitate risk assessments (e.g., GAMP, FMEA) and ensure appropriate mitigation strategies are implemented.
* Evaluate impact of deviations, changes, and CAPAs on system compliance and patient/data integrity.
* Support internal and external audits, including preparation, response to findings, and corrective action follow-up.
* Ensure adherence to 21 CFR Part 11, GAMP 5, GCLP, GCP, and data integrity principles.
* Escalate critical quality issues promptly and contribute to root cause analysis and remediation planning.
* Mentor junior team members and contribute to continuous improvement of QA processes.
Profile Requirements
Education & Experience:
* Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field.
* 4–6 years of progressive experience in Quality Assurance within pharmaceutical, biotech, or clinical diagnostics environments.
* Proven experience in computerized systems validation (CSV) and equipment qualification (IQ/OQ/PQ).
Technical Knowledge:
* In-depth knowledge of regulatory requirements: 21 CFR Part 11, GAMP 5, GCLP, GCP, ISO 9001:2015.
* Strong expertise in quality systems: Deviations, Change Control, CAPA, Non-Conformances, and Audit Management.
* Solid understanding of risk management methodologies and tools (e.g., FMEA, HACCP, risk-based validation).
Skills & Competencies:
* Excellent communication and stakeholder management skills across technical and non-technical audiences.
* Ability to lead quality discussions and influence decisions in a matrix organization.
* Fluent in English (written and spoken); additional languages a plus.
* Strong organizational and time management skills with ability to prioritize in a fast-paced environment.
* Proficient in Microsoft Office and electronic document/content management systems (EDMS, LIMS, etc.).
* Analytical mindset with attention to detail and a proactive approach to problem-solving.
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.