Country Clinical Quality Manager

Audits & Inspections:

- Primary point of contact for MRL Quality Assurance and Regulatory Agencies

- Manage and support activities during an audit/inspection

- Perform, facilitate and manage root-cause-analysis, Corrective and Preventive Actions (CAPAs) as well as responses to audit/inspection findings / reports.

- On a regular basis look into local trends, facilitate root-cause-analysis (if necessary) and coordinate the development of local action plan.

-Mandatory to have solid experience in audit and inspection, especially inspected by Taiwan FDA, US FDA, EMA, or PMDA is a plus.

Processes & Regulations:

-Local expert for ICH-GCP , local regulations and any quality-related process.

-Manage the local SOP/SME network to ensure a proper implementation of global/regional/local procedures and the regular update of local SOPs.

-Identify process improvement opportunities and properly escalate to the RCQM, CQM Lead and/or Process Owner (if necessary).

-Lead or Co-Lead global/regional /local key initiatives/projects/process improvement activities upon request of the RCQM/CRD.

-Have experience in process development is a plus.

Training:

- Local training point of contact and the liaison between local GCTO and MRL Learning & Development.

- In close cooperation with country operations management, identify local training needs and coordinate related activities.

-Deliver quality topics (as needed)

-Have experience in delivering training/workshop associated with quality topic is a plus.

Quality Control (QC) Activities:

-Coordinate and oversee proper execution of all QC activities at country/cluster i.e. In-house Quality Control Plan (IHQCP), Quality Control Visits (QCVs), etc.

-Perform QC activities and site visits (when required)

-Look into local trends, perform a root-cause-analysis (if necessary) and develop a local action plan.

-Have experience in site co-monitoring or oversight visit is a plus.

Quality / Compliance / Privacy Issue Escalation:

• Communicate/escalate quality/compliance issues (incl. any potential trends) to local

country operations management, CQM Lead and RCQM as appropriated.

• Escalate significant quality/compliance issues and supports investigations (fact finding,

root-cause-analysis). Support the reporting of Serious Breaches where applicable.

• Serve as local POC or supports local POC in case of escalations/reporting of Privacy

Incidents, if applicable

Required Education and Experience

• Bachelor's Degree or equivalent in relevant health care area. Preferred advanced degree, (e.g., Master degree, MD, PhD)

• At least 13 years experience in clinical research, with at least 6 years of direct monitoring experience in clinical research and with at least 3 years project management experience in clinical research. Only working experience in global pharma/CRO will be counted and considered. If local pharma/CRO experience will have 0.5 adjustment of the working experience.

• Relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.

• Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.

• Demonstrated experience leading / participating in cross-functional teams.

• Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.

• Experience in quality management / compliance (e.g. audit/inspection support incl. CAPA management, SOP management, compliance issue management, training, etc. )