Quality Assurance/Regulatory Affairs- Clinical Research

The role involves supporting clinical development projects by overseeing quality assurance activities related to clinical supplies, equipment, and associated processes. Responsibilities include ensuring compliance with relevant regulations, standards, and internal procedures; maintaining documentation for audits and inspections; and coordinating with project teams to implement quality and regulatory requirements across clinical trials. The individual will assist in reviewing and updating quality management systems, participate in internal and external quality audits, and help assess and mitigate quality and regulatory risks. The role also requires close collaboration with supply chain, operations, and regulatory teams to ensure that clinical materials and processes align with global and local regulatory expectations.
Qualifications
Strong knowledge and practical experience in Quality Control and Quality Assurance within clinical research or related life sciences domains.
Experience with Quality Management systems and processes, including documentation, change control, and continuous improvement initiatives.
Understanding of Good Manufacturing Practice (GMP) principles as applied to investigational products, medical devices, or clinical supplies.
Exposure to Quality Auditing activities, including planning, conducting, and responding to internal and external audits.
Bachelor’s or Master’s degree in life sciences, pharmacy, biomedical engineering, or a related discipline.
Familiarity with clinical trial regulations and guidelines (e.g., GCP, local regulatory requirements) and their application to clinical supply chains.
Strong analytical, documentation, and problem-solving skills, with attention to detail and accuracy.

Work arrangement
No