Country Clinical Quality Manager Colombia

hace 5 meses

Bogota, Colombia MSD A tiempo completo

**The Country Clinical Quality Manager** oversees all Clinical Quality Management activities in the respective country/cluster with the objective to delivered and sustained patient safety and high-quality data in compliance with company requirements and regulations.

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

The **Country Clinical Quality Manager** role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the Country Clinical Quality Manager support audits, inspections as well as Quality Control and local training activities

**Qualifications**:

- Bachelor's 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, Good Clinical Practice 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, organizational and prioritization 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.

**Functions and **Responsibilities**

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 Regional Director, Clinical Quality Management and/or Global Process Owners (if necessary). - Leads continuous quality improvements activities at the country level as agreed with Country/Cluster Clinical Research Director and Regional Director, Clinical Quality Management 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 Research & Development Division 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 Quality Control 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-causeanalysis 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 oper

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