QA Systems and Compliance Expert

Location: Baarle-Nassau, Netherlands.We are seeking a QA Systems and Compliance Expert (m/f/d) to help us maintaining and developing the quality system and compliance state of the Novartis Radioligand Therapies Site Baarle-Nassau (RLT Baarle-Nassau). He/she is responsible for the implementation of standards and procedures to ensure that the site complies with regulatory and GMP compliance requirements as described by authorities and by the Novartis quality manual. The role also ensures governance and quality oversight of external suppliers and the goods supplied to the site. The role is considered as a key support of the QA Systems Manager who is the operational manager of the role. Key Responsibilities: • Maintain the site’s quality system and ensures the QA system is compliant to regulatory and GMP compliance requirements.• Support GAP assessments and implementation of global Novartis procedures into the site’s quality management system, as well as support the QA systems documentation and review process; defines updates and approve Quality systems documents and records.• Represent RLT Baarle-Nassau in selected global projects and initiatives.• Ensure quality systems related reports and records are approved on time: self-inspection planning, quality plan, training plans, etc. Also help in the definition of training requirements for the site and ensure that appropriate GMP training is given to the applicable site associates.• Ensure that the site’s Quality KQI’s are monitored and reported. Support the drafting, and presentation of different quality oversight meetings and processes such as quality management review meeting or quality review board. But also perform the RLT Baarle-Nassau’s Annual Product Quality Reviews (PQR’s) on time and ensures that appropriate CAPA’s are defined and initiated.• Support the preparation of Health Authority inspections and responses, not to forget to collaborate in the coordination of continuous improvement projects linked to RLT Baarle-Nassau Quality system.• Responsible for ensuring quality oversight for materials purchased at or services provided by external partners (suppliers, contract manufacturers, service providers, etc.).• Ensure that external suppliers are governed according Novartis procedures. Negotiate quality agreements, plan audits, follow-up on audit CAPA’s and ensures external quality risk assessments are in place. Responsible for the qualification of new suppliers.