Quality Assurance Manager – R&D
23 ore fa
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, labeling, storage, and distribution, as well as pharmacovigilance activities associated with clinical research.Essential FunctionsDevelop, 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, labeling, 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 risk assessments within the R&D scope.Support and deliver training on quality and compliance topics to R&D staff.Contribute to the definition and implementation of strategies for process improvement and quality enhancement.To support COM Office during any type of Regulatory AuditTo be constantly updated on industry regulations and quality newsTo Acts as the archivist of the CMO office, ensuring R&D data is archived as per applicable regulations.RequirementsDegree in a scientific discipline (Chemistry, Biotechnology, Pharmacy, Engineering, or equivalent).At least 5 years of experience in Quality Assurance or Quality Management, preferably within R&D or technical functions.Strong knowledge of relevant standards and regulations (GCP, GVP, GMP, GLP, ISO , ISO , ICH Q10 etc.).Proven experience with GMP for IMPs, GCP, and regulatory requirements for clinical research.Experience with pharmacovigilance processes and strong familiarity with GVPs, EMA / PV systems and other related compliance requirements.Experience in vendor qualification and management, including CMOs and transport / logistics providers.Proven experience in managing quality systems, validation activities, and technical documentation.Excellent organizational, leadership, and problem-solving skills.Fluent in English and another language at least, an additional language knowledge is a plus.Soft SkillsAnalytical mindset and attention to detail.Ability to work effectively in cross-functional teams.Proactive attitude and focus on continuous improvement.Strong communication and interpersonal skills.#J-18808-Ljbffr
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