Quality Assurance Manager – R&D

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/870cfq

Summary of Position
The Quality Assurance Manager – R&D; ensures that all research, development, and validation activities are conducted in full compliance with company quality standards, applicable regulations, and international guidelines. This role leads the implementation and continuous improvement of quality processes within the R&D; department, fostering a strong culture of quality and compliance. The role oversees quality aspects related to investigational medicinal products (IMPs), including manufacturing, packaging, labelling, storage, and distribution, as well as pharmacovigilance activities associated with clinical research.

Essential Functions
-Develop, implement, and maintain the quality management system applicable to R&D; activities (SOPs, work instructions, standards, etc.).
-Ensure compliance of R&D; projects assigned to CMO Office with relevant regulations (e.g., GCP, GVP, GMP, GLP, ISO, ICH, or other industry-specific requirements).
-Collaborate with R&D;, Manufacturing, Regulatory Affairs, Clinical Operations, and Pharmacovigilance to ensure proper documentation,



data integrity, and reporting.
-Manage quality agreements, ensuring that external partners operate in compliance with regulatory and company requirements.
-Supervise quality oversight of third-party partners involved in the manufacture, packaging, labelling, storage, and transportation of investigational medicinal products (IMPs).
-Oversee and approve validation studies, qualification protocols, and technical documentation related to R&D; and clinical supply activities.
-Support pharmacovigilance activities, including the collection, evaluation, and reporting of adverse events, in collaboration with the PV department.
-Ensure training and awareness of R&D; and clinical staff on quality, GxP, and safety reporting requirements.
-Plan and lead internal and external audits related to R&D; activities, including inspections by regulatory authorities.
-Manage deviations, CAPAs, change controls, and ri

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/870cfq