Quality Assurance Manager

NOVADIP Biosciences S.A.; Mont-Saint-Guibert; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

NOVADIP Biosciences S.A. seeks a senior QA professional to maintain the Quality Management System (QMS) and ensure GCP compliance across clinical operations.

The role focuses on Scilife eQMS administration, training management, and document control, with emphasis on deviations, CAPAs, audits, and inspection readiness. Responsibilities include supporting IT validation activities (about 10% of workload), conducting root-cause analyses, and contributing to continuous improvement initiatives.

Qualifications

• Minimum 10 years of GCP QA in pharma/biotech/clinical research.
• Expert-level Scilife knowledge: document management, training management, workflow administration, reporting.
• Proven experience with GCP quality systems, deviations, CAPAs, audits, and inspection readiness.
• Excellent written and verbal English communication skills.

Responsabilités

• Manage and maintain eQMS Scilife quality documents.
• Training administration, user support, and document lifecycle management.
• Handle deviations, CAPA follow-up, investigations, and effectiveness verification.
• Provide QA guidance to Clinical Operations to ensure GCP compliance.
• Support IT validation activities (approx. 10% workload) including validation reviews.
• Participate in continuous improvement and audit readiness initiatives.

Connaissances

Quality Management Systems

Scilife Admin & Doc Control

GCP knowledge

Deviation & CAPA Management

Internal Auditing

IT Validation (CSV)

Document Management & Training Systems

Description du poste

Responsible for supporting and maintaining the Quality Management System while ensuring compliance with internal procedures and GCP requirements.

Important Note:

Due to the highly specialized nature of this position, only candidates with a minimum of 10 years of hands-on experience in Good Clinical Practice (GCP) and advanced expertise in the administration and management of the Scilife eQMS platform will be considered. Candidates who do not meet both of these essential requirements will not be considered for the role.

Key Responsibilities:

• Manage and maintain quality documents within the eQMS platform Scilife, including:
  • Training administration and follow-up
  • User support and helpdesk activities
  • Document lifecycle management
  • Force reviews and periodic reviews
  • Document & training exports and archival activities
  • Management of obsolete documents
• Review and support quality documentation related to:
  • Clinical operations activities
  • Internal audits
• Manage and coordinate deviations related to clinical operations and audit activities, including investigation support, root cause analysis, CAPA follow-up, and effectiveness verification.
• Provide Quality Assurance support and guidance to Clinical Operations to ensure compliance with applicable GCP and internal quality requirements.
• Contribute to IT validation activities (approximately 10% of workload), including documentation review, validation support, and compliance oversight.
• Participate in continuous improvement initiatives and support inspection and audit readiness activities.

Key Skills:

• Quality Management Systems (QMS)
• Scilife Administration and Document Control
• In-depth knowledge of GCP
• Deviation and CAPA Management
• Internal Auditing
• IT Validation (CSV) is a plus
• Document Management and Training Systems

Minimum Mandatory Qualifications :

• Minimum 10 years of experience in GCP Quality Assurance within the pharmaceutical, biotechnology, or clinical research environment.
• Demonstrated expert-level knowledge of Scilife, including document management, training management, workflow administration, reporting, and system maintenance.
• Proven experience in managing GCP quality systems, deviations, CAPAs, audits, and inspection readiness.
• Excellent written and verbal English communication skills.