Country Clinical Quality Manager

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:

Adaptability, Adaptability, Clinical Quality Management, Clinical Research, Clinical Study Design, Clinical Systems Implementation, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Analytics, Global Initiatives, ICH GCP Guidelines, Medical Supplies, Medical Writing, Network Management, Operations Management, Preventive Action, Process Improvements, Quality Assurance (QA) Standards, Quality Control Management, Quality Initiatives, Regulatory Compliance, Risk Management, Strategic Planning, Strategic Thinking {+ 1 more}

Preferred Skills:

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