Country Clinical Quality Manager - CCQM

Job Description

It is critical that, for all our 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 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 6-8 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 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).
• Local expert for any quality-related local processes.
• 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 & DevelopmentDivision 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 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 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 of quality issues with locally selected suppliers.
• Supports the Quality Management System (QMS) assessment for local supplier qualifications and re-qualifications.

Research & DevelopmentDivision 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/Research & DevelopmentDivision Compliance/Global Privacy Office.

Global / Regional Key Initiatives / Projects

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

Required Skills:

Preferred Skills:

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Current Contingent Workers apply HERE

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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