Clinical Quality Manager

Overview

In this talent community role you will be connected with opportunities in clinical quality and regulatory environments. You will help ensure patient safety by upholding ICH-GCP standards and local regulations, supporting audits, and driving quality across studies. You collaborate with study teams and auditors to monitor compliance and implement preventive actions. This is a proactive, ongoing engagement with cross-functional teams at a global CRO with a mission to improve patients’ lives.

Pay / Benefits

• competitive compensation package
• comprehensive benefits
• opportunity for personal and professional growth
• collaboration and innovation
• impact on patient well-being
• rewarding environment

Responsibilities

• Provide guidance on clinical quality, ICH-GCP, and local regulatory requirements to study teams
• Serve as main contact for auditors and support audits and inspections
• Drive quality control activities and monitor compliance in clinical studies
• Identify quality risks and ensure corrective and preventive actions are implemented
• Develop, maintain, and implement local procedural documents and quality frameworks

Key requirements

• Bachelor’s degree in life sciences or related
• ≥5 years of experience in the pharmaceutical industry (Development Operations or Quality Assurance preferred)
• Strong knowledge of ICH-GCP and local clinical trial regulations
• Good understanding of drug development processes and GxP requirements
• Excellent communication, organizational, and problem-solving skills
• communication
• organization
• problem-solving
• ICH-GCP
• local clinical trial regulations
• GxP

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