Country Clinical Quality Manager

Job Description

Regulations & Processes:

• Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes).
• In close collaboration with local country operations management, manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs).
• Local expert for any quality-related local processes.
• Identifies process gaps / opportunities for process improvement and properly escalates to RCQM and/or Global Process Owners (if necessary).
• Leads continuous quality improvements activities at the country level as agreed with Country/Cluster CRD and RCQM and supports or co-leads continuous improvements activities at the global/regional level. Training:
• Local training point of contact and the liaison between local country operations and Learning & Development (L&D).
• In close cooperation with local country operations management, identifies / coordinates local training needs.
• Supports local trainings (as needed). Quality Control (QC) Activities:
• In conjunction with the local country operations management, coordinates and oversees all QC activities. This includes to ensure a proper execution of the In-house Quality Control Plan (IHQCP), the Quality Control Visits (QCVs) as well as any other QC Checks.
• In mutual agreement with local country operations management and the RCQM, performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.
• On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary), develops local action plan (incl. sharing of results and training of local country operations, if required).

Audits & Inspections:

• Primary local point of contact for Quality Assurance and Regulatory Agencies.
• Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection.
• In cooperation with local country operations and/or headquarters, performs root-cause analysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates/facilitates the responses to audit/inspection reports.
• On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary) and develops local action plan (incl. sharing of results and training of local country operations, if required). Quality / Compliance / Privacy Issue Escalation:
• Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM.
• Escalates significant quality/compliance issues and supports investigations (fact finding, root-cause-analysis) as well as the reporting of ‘Serious Breaches’, if applicable.
• Serves as local POC or supports local POC in case of escalations/reporting of Privacy Incidents, if applicable.

Clinical Supplies GCP Investigations

• Evaluates trends on Clinical Supply GCP Inquiries and incorrect management of clinical supplies.
• Coordinates GCP Investigations of trends related to Clinical Supply GCP Inquiries and incorrect management of clinical supplies (if necessary).

Supplier Qualification:

• Leads local supplier qualifications and re-qualifications of locally selected suppliers and supports solving of quality issues with locally selected suppliers.
• Supports the Quality Management System (QMS) assessment for local supplier qualifications and re-qualifications.

Compliance & Privacy Steward:

• Supports implementation of divisional compliance/privacy initiatives and reporting at the local level.
• Communicates compliance/privacy concerns to local legal/compliance/privacy department and/or Compliance/Global Privacy Office.

Global / Regional Key Initiatives / Projects

• Supports global/regional key initiatives/projects upon request of the RCQM.

Candidate qualification requirements:

• Bachelor's Degree or equivalent in relevant health care area, preferably in pharmaceutical, nursing, biotechnology or related fields.
• A minimum of 6-8 years of direct experience in clinical research, clinical trial operations including direct field monitoring experience, CRA experience is preferred.
• Experience in management/oversight with a demonstrated record of accomplishments.
• Experience in Clinical Research In-Country Operations.
• Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations.
• Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
• Ability to demonstrate in leading cross-functional teams.
• Experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement, audits and inspections.
• Ability to coordinate and deliver training sessions.
• Skillful in AI, data analytics, and automation to enhance and optimize clinical quality management processes and decision making.

*This position is on an individual contributor-basis*

Required Skills:

Preferred Skills:

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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