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Job Description
Join a Leader in Pharmaceutical Excellence – Eurofins CDMO Alphora is looking for a Manager, Quality Systems and Compliance
Are you passionate about driving quality and compliance in a dynamic, science-driven environment? Eurofins CDMO Alphora Inc. is seeking a Manager, Quality Systems and Compliance to lead our Compliance team in upholding and advancing our Quality Management System (QMS). This pivotal role ensures our operations meet and exceed cGMP standards, supporting the development and manufacture of safe, effective pharmaceuticals for both clinical trials and commercial markets.
As a key leader, you will oversee the implementation of robust quality systems across all cGMP business units—including Drug Substance, Drug Product, and Biologics. From managing audits and regulatory submissions to spearheading validation programs and continuous improvement initiatives, you’ll play a critical role in shaping the quality culture of our organization.
What You’ll Lead:
- Development and maintenance of QMS for cGMP compliance
- Regulatory and client audit management, CAPA oversight
- Validation and qualification programs for facilities, equipment, and processes
- Quality metrics, data analytics, and training programs
- Change control, document management, and vendor oversight
- Regulatory support for commercial programs and site licensing
This is more than a compliance role—it’s a leadership opportunity to influence quality excellence and patient safety on a global scale.
