Job content
As a QA Manager, you will be responsible for developing, implementing and safeguarding the quality policy. You ensure that the processes comply with internal guidelines and relevant laws and regulations. Patient safety is our top priority.
– You monitor and oversee the quality system
– You support and advise on questions regarding quality, laws and regulations
– You keep up to date with the latest developments in laws and regulations regarding clinical studies and assess the impact of these on our client’s policy
– You assess the quality documents and ensure that employees carry out studies in accordance with SOPs and WIs and standard forms
– You make an important contribution to continuous improvement of quality, quality awareness and efficiency
– You act as a point of contact for external clients with regard to quality
– You ensure correct follow-up of complaints, relevant deviations and deviations
– You perform internal and external audits, including preparation and follow-up of corrective measures
– You advise and support (FDA/EMA) audits and inspections
– Escalates serious findings to management
– Provides training in the field of quality and safety
– You manage a team of 2 QA officers
Profile
– You have at least 5 years of work experience in a position within clinical drug research as a quality manager, including several years in a management role
– You have a (para)medical background at HBO or academic level
– You have demonstrable knowledge of Good Clinical Practice (certificate)
– You have knowledge of procedures and other laws and regulations relevant to clinical scientific research based on education or work experience
– Medical content knowledge in the field of hemato-oncology based on education or work experience is an advantage
– You have excellent computer skills and have affinity/experience with managing (clinical) databases and information systems
– You have a good command of the Dutch and English language, both verbally and in writing, and have excellent communication skills