Job Description
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 on achieving those objectives.
Under the guidance of the Director, Country Quality Management, 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.
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 Director, CCQM and/or Global Process Owners (if necessary).
• Leads continuous quality improvement activities at the country level, as agreed with Country/Cluster CRD and Director, CCQM, and supports or co-leads continuous improvement activities at the global/regional level.
Training:
• Local training point of contact and the liaison between local country operations and R&D 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 ensuring the proper execution of the In-house Quality Control Plan (IHQCP), Quality Control Visits (QCVs), and any other QC Checks.
• In mutual agreement with local country operations management and the Director, CCQM, 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 R&D 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 a 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 Director, CCQM.
• 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.
R&D Compliance & Privacy Steward:
• Supports the implementation of divisional compliance/privacy initiatives and reporting at the local level.
• Communicates compliance/privacy concerns to local legal/compliance/privacy department and/or R&D Compliance/Global Privacy Office.
Global / Regional Key Initiatives / Projects
• Supports global/regional key initiatives/projects upon request of the Director, CCQM.
Required Skills:
Clinical Development, Clinical Trial Development, Clinical Trials Monitoring, Clinical Trials Operations, Communication, Data Analysis, Ethical Standards, Good Clinical Practice (GCP), ICH GCP Guidelines, Quality Management, Root Cause Analysis (RCA)Preferred Skills:
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
50%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
12/31/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.