Global Clinical Quality & Compliance Lead

Cochlear Ltd; Belgique; Sur place; EUR 80 000 - 110 000; Plein temps

Résumé du poste

Cochlear Ltd is seeking a Clinical Quality and Compliance (CQC) Manager to strengthen quality, compliance and systems for global clinical research activities. You will collaborate with CSI, CLTD, CBAS, investigators and vendors, providing GCP and ISO 14155 expertise, audits, and QA support.

This role combines clinical research quality with hands-on system and stakeholder work in a global, purpose-led organization. Travel locally and internationally may be required.

Qualifications

• Bachelor's degree in Healthcare, Life Sciences, Nursing, Public Health or equivalent.
• Minimum 5 years' clinical trials experience within the medical device, pharmaceutical or biotechnology industry.
• Practical knowledge of GCP, preferably ISO 14155, clinical regulations, GDP and privacy principles.
• Experience contributing to quality management documentation such as SOPs, issue management or metrics.
• Strong attention to detail with excellent organisational, time management and communication skills.
• Comfortable working independently and across time zones.

Responsabilités

• Support CQC quality management activities including QMS change management and updates to CQC‑owned QMS processes.
• Provide SME on GCP, ISO 14155, GDP and local clinical investigation regulations.
• Support implementation of new or revised clinical research standards and regulations.
• Contribute to clinical investigation quality oversight including document checks and milestone reviews.
• Contribute to QA through risk and issue management, audit readiness and remediation reporting.
• Act as a Clinical Business and System Administrator for Vault Clinical.
• Partner with regional stakeholders on privacy, outsourcing and contracts.
• Identify and drive continuous improvement across quality management and clinical systems.

Connaissances

Attention to detail

Organisational skills

Communication skills

Team collaboration

Willingness to travel

Formation

Bachelor's degree (Healthcare, Life Sciences, Nursing, Public Health)

Outils

Vault Clinical

Description du poste

Cochlear Ltd is seeking a Clinical Quality and Compliance (CQC) Manager to strengthen quality, compliance and systems for global clinical research activities. You will collaborate with CSI, CLTD, CBAS, investigators and vendors, providing GCP and ISO 14155 expertise, audits, and QA support.

This role combines clinical research quality with hands-on system and stakeholder work in a global, purpose-led organization. Travel locally and internationally may be required.