Job Description

Company

National Cancer Centre Singapore



The Senior Manager shall provide support to research teams to ensure audit/inspection readiness and be actively involved in quality management processes to assure compliance with relevant regulations (Human Biomedical Research Act (HBRA), Health Products and Medicines Act), Good Practice quality guidelines (GXP), SingHealth and NCC Standard Operating Procedures (SOPs) and research protocols.

Compliance Management * Support and assist research teams with pre-audit/inspection preparation to ensure readiness and compliance with relevant regulations, GXP and SOPs and research protocols:

• Provide advice and information on regulatory requirements;
• Assist research teams to prepare dossiers and responses to audits/inspections;
• Act as primary point of contact with auditors/regulatory inspectors;
• Assist research teams to review, evaluate and implement Corrective and Preventive Action (CAPA) Plans according to specified time frame.

Quality Management * Work with management, internal and external stakeholders to assure proper research governance and practices:

• Review and analyse audit/inspection findings;
• Identify and track research quality metrics;
• Identify, recommend and implement quality improvement and compliance initiatives.
• Perform any other duties assigned by the supervisors or the Clinical Trials Office higher management staff

Job Requirements

• A recognised degree, with at least 15 - 20 years of relevant healthcare or research setting.
• Possess breadth of knowledge and experience in relevant research regulations (HBRA, Health Products and Medicines Act) and Good Practice quality guidelines (GXP).
• Experience in quality assurance or related activities.
• Meticulous and responsive with excellent communication and writing skills.

Job Category

Research

Education Level

Bachelors Degree

Job Function

Administration Support, Research & Development, Research / Survey Services

Employment Type

Contract Full Time