For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
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For our QA team located in Erkrath, Germany we are seeking an experienced and highly motivated

2. Validation & Qualification

• Contribute to computer system validation (CSV) and equipment qualification activities across departments.
• Support the implementation and use of electronic tools for equipment qualification and documentation management.
• Review and approve study-related records with a focus on process optimization and data integrity

YOUR ROLE:

As QA Team Lead, you will oversee a team of 2–4 QA Specialists / Auditors and play a central role in ensuring regulatory compliance and operational excellence across computerized systems, equipment qualification, internal inspections and evaluation of quality metrics. Your work will support both site-level and cross-functional/global quality initiatives.

YOUR KEY RESPONSIBILITIES:

1. Quality Oversight & Compliance

• Ensure that computerized systems and testing equipment comply with global regulatory requirements and internal CRL standards.
• Approve the implementation and maintenance of such systems to ensure ongoing control and quality.
• Continuously monitor and improve systems and procedures to ensure compliance and efficiency.
• Identify and escalate compliance gaps; contribute to the development and revision of policies and SOPs.
• Provide compliance expertise and guidance to QA teams and stakeholders across functions.

1. Validation & Qualification

• Contribute to computer system validation (CSV) and equipment qualification activities across departments.
• Support the implementation and use of electronic tools for equipment qualification and documentation management.
• Review and approve study-related records with a focus on process optimization and data integrity.

1. Inspections, Metrics & Risk Management

• Plan and conduct risk-based internal inspections (labs, facilities, systems); write inspection reports and monitor related CAPAs.
• Track and trend key aspects of the Quality System and generate regular reports for management.
• Compile monthly Quality metrics and contribute to the preparation of the Quarterly Management Review (QMR).

1. Team Leadership & Collaboration

• Lead, coach, and develop a team of 2–4 QA Specialists/Auditors.
• Foster strong cross-functional relationships across a matrix organization.