Senior Manager Quality Assurance (Qualified Person)

Division Oncology
Funktionsbereich Quality
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 250313BR


Purpose of the role:
Independent supervision, without any interference of third persons, of the manufacturing processes of the site, related to the drug manufacturing license. With respect to the quality of the medicinal products, assurance of compliance to the national Medicines Law and other applicable regulations and together with the Head of Production maintaining an effective implementation, monitoring and maintenance of a GMP-compliant quality system.

Key Accountabilities:
• Design and implementation of a GMP – compliant quality system within affiliate
• Auditing of contract manufacturers when not covered by corporate
• Assessment and release of manufactured medicinal products
• Release of incoming goods
• Maintenance of the Quality Manual including internal audits
• Coordination of recall operations
• Complaint handling of customers
• Assessment and processing of deviations and CAPA’s
• Maintaining professional contacts with the Health Care Inspectorate
• Providing support regarding pharmaceutical issues to clients and employees
• Training of employees with respect to GMP
• Release of goods placed in quarantine
• Report QA activities to QA corporate
• Escalate information to the management and QA corporate in case of product quality issue
• Ensuring all production operations comply to GMP, GDP and internal standards

Quality and Quality Manual
• The safeguarding of the quality of the medicinal products which have been manufactured by the radiopharmaceutical site.
• Safeguarding of the compliance with the GMP requirements within the organization based on the activities as described in the Quality Manual

This role is based in Bonn.



Qualified as QP conform to § 15 Abs. 3a AMG (German Drug Act) and has at least three years' experience in the field of nuclear medicine or that of radiopharmaceutical chemistry

4+ years of experience in a high tech production environment as a QP
Strong affinity with and awareness of quality issues
People skills
Open and clear collaboration and communication to make sure the daily production operation runs smoothly
Exploitation of new technology and techniques to eliminate non-value adding activities and improve productivity / performance through new processes
Shows the appropriate sense of urgency around given tasks

German and English fluently, verbally and in writing

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