Description

Lead quality assurance projects in pharmaceutical and medical device sectors, focusing on cell therapy manufacturing and cloud-based data management.

Responsibilities

• Develop remediation plans for cell therapy manufacturing data integrity and transition unstructured requests into structured, risk-based projects.
• Assess quality approaches for cloud-based scientific data management system implementations, including validation and qualification needs across multiple geographic areas.
• Execute medical device remediation projects using risk-based approaches to address audit findings and recurring issues via data analysis and AI technology.
• Mentor and coach internal Quality Engineers and IT staff on risk-based approaches, regulatory compliance, and liaison strategies.
• Act as a mediator between technical teams and regulatory bodies to ensure adherence to industry standards.

Required Skills

• 3+ years of experience in quality assurance and regulatory compliance within the pharmaceutical and medical device sectors.
• Expertise in cell therapy manufacturing and medical device remediation.
• Experience with cloud-based data management systems.
• Knowledge of GMP, GLP, and GxP regulatory standards.
• Familiarity with Agile Software Development Lifecycle.
• Experience using Jira.
• Fluency in German.
• Ability to work across multiple time zones, including USA, Europe, and Japan.

Preferred Skills

• Knowledge of Lean methodologies.
• Established professional network within the pharmaceutical industry.

Key Skills

Education

ANY GRADUATE