Country Clinical Quality Manager- Colombia
hace 2 semanas
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
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.
**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 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 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 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)
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