This role leads the implementation and continuous improvement of quality processes within the R&D department, fostering a strong culture of quality and compliance
Job Summary
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.
Plan and lead internal and external audits related to R&D activities, including inspections by regulatory authorities.
Matching Summary
This role leads the implementation and continuous improvement of quality processes within the R&D department, fostering a strong culture of quality and compliance.
Skills & Requirements
Must-have
Quality Management System implementation
Regulatory compliance GCP GVP GMP GLP
Investigational Medicinal Products oversight
Vendor qualification and management
Audit planning and execution
Deviation CAPA change control management
Nice-to-have
Analytical mindset and attention to detail
Proactive attitude and continuous improvement
Strong communication and interpersonal skills
Cross-functional team collaboration
Key Requirements
Degree in scientific discipline
5+ years Quality Assurance experience
Knowledge of GCP GVP GMP GLP ISO ICH
Experience with GMP for IMPs and clinical research