(.) Manager, Country Clincial Quality Management

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 Country Clinical Quality Manager (CCQM) position has a significant impact on achieving those objectives.

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

Job 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 the Regional Clinical Quality Manager (RCQM) and/or Global Process Owners (if necessary).

Leads continuous quality improvement activities at the country level as agreed with Country/Cluster CRD and RCQM 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 the Learning & Development (L&D) team.

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 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 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 alocal action plan (incl. sharing of results and training of local country operations if required).

Audits & Inspections:

Primary local point of contact for our 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 RCQM.

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 quality issues with locally selected suppliers.

Supports the Quality Management System (QMS) assessment for local supplier qualifications and re-qualifications.

R&D Departments 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 R*D Departments Compliance/Global Privacy Office. Global / Regional Key Initiatives / Projects.

Supports global/regional key initiatives/projects upon request of the RCQM.

Job Requirements:

Qualifications:

Bachelors Degree or equivalent in a 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 GCP and other clinical research-related regulations.

Solid track record of initiating planning and delivering 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.

Required Skills:

Preferred Skills:

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Current Contingent Workers apply HERE

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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