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 RCQM and/or headquarters (if necessary).
  • Leads continuous improvements activities at the country level 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 the internal Institute.
  • In close cooperation with local country operations management, identifies local training needs and initiates local training activities.
  • Supports onboarding of local country operations personnel (quality‐related topics).
• Quality Control (QC) Activities:
  • In conjunction with the local country operations management, coordinates and oversees all Quality Control activities (local quality plan) by ensuring a proper execution of the Inhouse Quality Control Plan (IHQCP) as well as the Quality Control Visits (QCVs).
  • In mutual agreement with local country operations management and the Regional Clinical Quality Manager, performs QC activities (incl. QCVs).
  • On a regular basis and in collaboration with local country operations, looks into 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 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, looks into 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 Issue Escalation:
  • Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM.
  • If indicated, escalates quality/compliance issues to Quality Assurance and/or Compliance. 
  • Local POC for escalations of Privacy Breaches that occurred in clinical trials, or supports local POC for escalations of Privacy Breaches, if necessary.
  • Compliance Steward (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).
• Vendor Qualification:
  • Leads local vendor qualifications of locally selected vendors and supports solving of quality issues with locally selected vendors. 
  • Supports the Quality Management System (QMS) assessment for global and local vendor qualifications.

Education:

• 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.
• Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
• Demonstrated experience leading cross‐functional teams of business professionals.
• Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
• Ideally, experience in managing audits and inspections.
• Ideally, experience in coordinating and delivering training sessions.

Skills:

• Superior oral and written communication and people management skills in an international environment.
• Excellent project management and organizational skills.
• Excellent teamwork and leadership 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.