Country Clinical Quality Manager

Under the guidance of the Regional Director Clinical Quality Management (RCQM) the CCQM oversees all CQM activities in the respective country/cluster.

The role requires the ability to properly implement local/global processes/procedures to identify opportunities for process improvement and to support continuous improvement addition the CCQMs support audits inspections as well as Quality Control and local training activities.

Qualifications Skills & Experience Qualifications:

Bachelors Degree or equivalent in relevant health care area.

Experience:

- A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals with a demonstrated record of accomplishments. Experience in Country Operations preferred.

- 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.

- Demonstrated experience in leading cross-functional teams.

- Ideally experience in Clinical Quality Management including Quality Control Activities Process Management & Improvement.

- Ideally experience in managing audits and inspections.

- Ideally experience in coordinating and delivering training sessions.

Skills:

- Superior oral and written communication and leadership skills in an international environment.

- Excellent project management and organizational skills.

- Excellent teamwork skills including conflict resolution expertise and discretion.

- Ability to analyze interpret and solve complex problems.

- Ability to think strategically objectively and with creativity and innovation.

- Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.

Functional Area

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 MRL 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 MRL 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 rootcause-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.

MRL 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 MRL Compliance/Global Privacy Office.

Global / Regional Key Initiatives / Projects

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

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