Manager, Country Clinical Quality Management, GCTO

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:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

50%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job 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.

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