(Asso./Sr.) 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 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:

Preferred Skills:

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

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