[Remote] International License Partner Quality Specialist
Note: The job is a remote job and is open to candidates in USA. Lantheus is a leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to find, fight, and follow disease. They are seeking an International License Partner Quality Specialist to support the implementation and execution of quality oversight and compliance of international license partners manufacturing radiopharmaceuticals.
Responsibilities
ā¢ Collaborate closely with internal Quality teams and International license holders (LH) and contract manufacturers to ensure compliance with applicable GMP, and other regulatory requirements, as well as Lantheus quality standards
ā¢ Support the implementation, operation, and continuous improvement of Lantheus systems and procedures for LH and international contract manufacturer quality management
ā¢ Ensure that international contract manufacturer and LH are quality assessed for suitability and monitored for continuing compliance to applicable GXP regulations and Lantheus requirements, including:
ā¢ Acting as point of contact for quality related aspects
ā¢ Monitoring quality performance, maintaining oversight trackers, and ensuring timely identification, escalation, and reporting of deviations from approved processes and standards
ā¢ Support improvement of processes to help maintain required product quality, evaluation of deviations, investigation of out-of-specification results, CAPAs and product complaints as needed
ā¢ Implementation, management and follow-up of audits at license partners
ā¢ Negotiation and maintenance of quality assurance agreements
ā¢ GMP-compliant processing and management of change control requests
ā¢ Review and approval of plans and reports for the technology transfer to license partners
ā¢ Reporting and correction of deviations from standards in accordance with applicable processes
ā¢ Support in the presentation of quality requirements, e.g., through involvement in the preparation of QA documentation
ā¢ Active participation in discussions on the optimization of processes to efficiently improve the level of quality
Skills
ā¢ Master of Science degree in chemistry, pharmacy or related scientific discipline
ā¢ Minimum of 5 years of experience in regulated, international pharmaceutical manufacturing environment, preferably in radiopharmaceuticals
ā¢ Solid knowledge of international guidelines and quality standards applicable to radiopharmaceuticals (e.g. PIC/s, ICH and WHO)
ā¢ Experience working with external partners, license holders, or contract manufacturing organizations
ā¢ Strong communication skills and the ability to collaborate effectively across functions and cultures
ā¢ Sound organizational and project management skills, with the ability to manage multiple activities in parallel
ā¢ Proficiency in Microsoft Office 365 and ability to learn specialized software
ā¢ Fluency in English
Company Overview
ā¢ Life Molecular Imaging is a heal diagnostic center that provides neuroimaging and cardiovascular imaging services. It was founded in 2012, and is headquartered in Berlin, Berlin, DEU, with a workforce of 51-200 employees. Its website is https://life-mi.com.
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Responsibilities
ā¢ Collaborate closely with internal Quality teams and International license holders (LH) and contract manufacturers to ensure compliance with applicable GMP, and other regulatory requirements, as well as Lantheus quality standards
ā¢ Support the implementation, operation, and continuous improvement of Lantheus systems and procedures for LH and international contract manufacturer quality management
ā¢ Ensure that international contract manufacturer and LH are quality assessed for suitability and monitored for continuing compliance to applicable GXP regulations and Lantheus requirements, including:
ā¢ Acting as point of contact for quality related aspects
ā¢ Monitoring quality performance, maintaining oversight trackers, and ensuring timely identification, escalation, and reporting of deviations from approved processes and standards
ā¢ Support improvement of processes to help maintain required product quality, evaluation of deviations, investigation of out-of-specification results, CAPAs and product complaints as needed
ā¢ Implementation, management and follow-up of audits at license partners
ā¢ Negotiation and maintenance of quality assurance agreements
ā¢ GMP-compliant processing and management of change control requests
ā¢ Review and approval of plans and reports for the technology transfer to license partners
ā¢ Reporting and correction of deviations from standards in accordance with applicable processes
ā¢ Support in the presentation of quality requirements, e.g., through involvement in the preparation of QA documentation
ā¢ Active participation in discussions on the optimization of processes to efficiently improve the level of quality
Skills
ā¢ Master of Science degree in chemistry, pharmacy or related scientific discipline
ā¢ Minimum of 5 years of experience in regulated, international pharmaceutical manufacturing environment, preferably in radiopharmaceuticals
ā¢ Solid knowledge of international guidelines and quality standards applicable to radiopharmaceuticals (e.g. PIC/s, ICH and WHO)
ā¢ Experience working with external partners, license holders, or contract manufacturing organizations
ā¢ Strong communication skills and the ability to collaborate effectively across functions and cultures
ā¢ Sound organizational and project management skills, with the ability to manage multiple activities in parallel
ā¢ Proficiency in Microsoft Office 365 and ability to learn specialized software
ā¢ Fluency in English
Company Overview
ā¢ Life Molecular Imaging is a heal diagnostic center that provides neuroimaging and cardiovascular imaging services. It was founded in 2012, and is headquartered in Berlin, Berlin, DEU, with a workforce of 51-200 employees. Its website is https://life-mi.com.
Apply tot his job
Apply To this Job