Merck Country Clinical Quality Manager, US - Remote Boise, Idaho Apply Now
It is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The CCQM position has a significant impact in achieving those objectives.
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 initiatives. In addition, the CCQMs 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 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, 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.
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).
- 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 our Research 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 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 our Research Division 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.
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.
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).
- 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.
Research Division 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 our Research Division's Compliance/Global Privacy Office.
Global / Regional Key Initiatives / Projects:
Supports global/regional key initiatives/projects upon request of the RCQM.
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