GCP Inspection Lead Asia Pacific Job - Taiwan
MSD are looking to appoint a GCP Inspection Lead within their Inspection Management department.
In joining the strong, multi-skilled, entrepreneurial GCP Inspection Management team, with members in The United States, Europe and Asia, you will be offered rewarding opportunities within clinical research and development.
This position provides a unique opportunity to work at the forefront of clinical development within one of the world’s premier biopharmaceutical companies managing regulatory Good Clinical Practice inspections of MSD, clinical investigator sites and vendors, within Asia but also worldwide.
The GCP Inspection Lead will coordinate the preparation, notification, conduct and follow-up of Health Authority inspections related to clinical study(ies) sponsored by MSD worldwide. He/she will collaborate with colleagues across Merck Research Laboratories (MRL) to ensure that Health Authority GCP inspections are adequately managed, supported, and facilitated. He/she will implement processes activities and training to ensure that MSD is prepared for any inspection. He/she will participate in and/or lead pre-approval inspections at MSD offices globally (i.e. sponsor-monitor) and of Clinical Investigator sites.
The GCP Inspection Lead will direct the overall management and support for inspections (MSD and clinical investigator sites) for major submissions in order to ensure that all phases of Health Authority inspections (i.e. preparation and facilitation, responses, root cause analysis, corrective action and preventive action (CAPA) are handled consistently, professionally and proactively and result in outcomes that demonstrate the Company’s commitment to high quality clinical research.
Extensive experience in clinical research, including direct prior involvement in worldwide Health Authority inspections (e.g. CFDA, FDA, EMA, PMDA, MHRA).
Experience conducting GCP audits and/or direct field monitoring experience, with a demonstrated record of accomplishments.
Good knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required.
Direct knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements.
Experience with delivering effective CAPA management solutions.
Superior oral and written communication skills in an international environment.
Proficiency in both English and Chinese (Oral and written).
Job: Clinical Research Generic Job Title:Assoc. Dir, Clinical Research
Primary Location: APAC-TW-TPE-Taipei
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
Job Segment: Inspection, Law, CAPA, Clinical Research, Engineering, Legal, Management, Research, Healthcare