Senior QA Manager, eQMS & GCP Compliance (Biotech)

Strandassociates; Corbais; Hybride; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Attractive salary

Very competitive extra-legal benefits

Homeworking possibilities

Training and workshops

Résumé du poste

Strandassociates invites a senior QA professional to lead eQMS administration and document control within Scilife, ensuring GCP compliance across clinical trials. You will drive deviations, CAPA, and audit readiness while supporting IT validation activities in a high-growth biotech setting.

The role requires extensive GCP experience, strong English communication, and autonomous work in a fast-paced environment. Based in Belgium with options for homeworking and hybrid work arrangements.

Qualifications

• Minimum 10 years of hands-on QA experience in GCP within pharma/biotech/CRO.
• Proven expertise in Scilife administration (workflow, training, reporting).
• Strong experience in managing GCP quality systems, deviations, CAPA, and inspection readiness.
• Fluency in professional English.

Responsabilités

• Lead eQMS administration and document control in Scilife.
• Oversee training administration, user support, reviews, lifecycle, reporting.
• Manage obsolete documents and ensure system maintenance.
• Provide QA guidance to ensure GCP compliance across clinical ops.
• Support deviations, CAPA, root cause analysis and investigations.
• Assist IT validation / CSV activities.

Connaissances

QMS & GCP regulations

Scilife administration

Deviations & CAPA

Internal auditing

IT validation / CSV

Outils

Scilife

Description du poste

Strandassociates invites a senior QA professional to lead eQMS administration and document control within Scilife, ensuring GCP compliance across clinical trials. You will drive deviations, CAPA, and audit readiness while supporting IT validation activities in a high-growth biotech setting.

The role requires extensive GCP experience, strong English communication, and autonomous work in a fast-paced environment. Based in Belgium with options for homeworking and hybrid work arrangements.