40+ is the dedicated number of team members you would be joining at IDB (Advanced Accelerator Applications, Netherlands) whose mission is to bring new therapies to patients wordwide by producing radiopharmaceuticals for targeted radioligand therapy. IDB 's team embraces the culture of empowerment and team work.
The QA Compliance Expert – internal and external governance ensures that the appropriate quality oversight is in place for both external partners of IDB (contractors, suppliers, contract manufacturers, etc.) and internal stakeholders. They ensure that quality governance is in place, that the KPI’s are designed/reported and that appropriate corrective actions in case of a negative trend are defined and implemented.
- External quality governance
- Responsible for ensuring quality oversight for materials purchased at or services provided by external partners (suppliers, Contract manufacturers, service providers etc.
- Ensures that quality agreements are in place with IDB’s external partners
- Participates in and approves changes of supplier qualification and certification status of all IDB’s external suppliers, and maintains all associated quality systems e.g. maintains and updates documents related to the supplier qualification and monitoring
- Ensures that materials produced at external partners meet Novartis/AAA/IDB quality and specifications
- Defines inspection plans of incoming goods and updates those plans if necessary
- Participate in quality escalations linked to material supply or quality oversight of external partners
- Responsible for coordinating and ensuring availability of supplier/material quality risk assessments according to Novartis/AAA procedures
- Represents IDB in global projects linked to supplier quality oversight
- Reviews and acts as SPOC for global supplier quality oversight standards and procedure
- Responsible for coordinating and ensuring that quality Auditing of external suppliers is carried out according to Novartis Quality Manual. Maintains and updates documents related to the audits in relevant systems and acts as follow-up responsible person (FURP) or QA responsible person (QARP)
- Supports business review meetings with suppliers from a quality perspective
- Ensures that quality systems are maintained and that AAA/Novartis procedures are implemented on time
- Ensures that IDB’s KQI’s are monitored and reported
- Supports the drafting, and presentation of different quality oversight meetings and processes such as quality management review meeting, quality review board
- Performs the IDB’s Annual Product Quality Reviews (PQR’s) on time and ensures that appropriate CAPA’s are defined and initiated
- Supports the preparation of Health Authority responses
- Supports and in some cases coordinates continuous improvement projects linked to IDB’s Quality system to improve overall compliance performance of the site
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Bachelor’s degree or Master’s degree in scientific area
Ideally 3-4 years of experience in a QA/QC area in pharmaceutical industry
Knowledge of cGMP
Initial experience in Project Management is recommended
Analytical mind-set and eye for detail
Open to new technologies and continuous improvement behaviour
Open and clear collaboration and communication with third parties
Shows the appropriate sense of urgency around given tasks
Dutch and English fluently, verbally and in writing.