(Asso./Sr.) Manager/Asso. Dir, Country Clincial Quality Management

Job description

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 initiatives. In 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 a local 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 Department’s 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 Department’s Compliance/Global Privacy Office. Global / Regional Key Initiatives / Projects. • Supports global/regional key initiatives/projects upon request of the RCQM. Job Requirements: Qualifications: • Bachelor's 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: CAPA Management, Clinical Research, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Data Analysis, ICH GCP Guidelines, Investigation Procedures, 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: 06/30/2026 *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.