• Provide guidance to the GM as to the quality status of their countries - and the actions required to support quality delivery
• Prepare an annual quality control plan with the respective operational leads based on prior client and Quality Assurance audits, regulatory inspections and the project specific operation plans
• Maintain, manage and co-ordinate the overall Quality Control (QC) plan for their region
• Ensure compliance with CAPAs, audit excellence, quality plan execution, QC metrics and quality training and communication as required
• Drive compliance to QC process and QC tools to ensure the integrity of metrics and performance
• Assist with promotion of a proactive quality culture

• Use of an annual quality plan including a process to collect, analyse and report on quality metrics across the regional business.

• Co-Chair the regional ‘Quality Improvement Forum’, reporting to the executive leadership.
• Communicate the business case to support recommendations for change to current business practices and processes
• Support Project Management in managing Project Key Quality Indicators (KQIs) and provide guidance on how to evaluate operations personnel compliance with the transfer of obligations defined by the project contract, and if required, the Master Services Agreement
• Partner with Senior Management, Global QA & Compliance, Country Leadership, Functional and project leadership in identifying and prioritising opportunities/needs to improve quality throughout the region
• Conduct quality review ‘deep dives’ with Functional Management, Senior Directors and Project Leads to identify quality issues, perform root cause analysis and deliver ‘lessons learned’ action plans to prevent recurrence of violations
• Work with Operational and QA personnel to ensure completion and resolution of Client and Quality Assurance audit findings, and the implementation of Corrective Action and Preventive Action (CAPA) plans for Confirmed Quality Issues (CQIs) and Clinical Quality Control visit findings. Facilitate sharing of best practices and lessons learned to ensure that identical findings do not occur again on other projects
• Ensure effective communication of quality control strategies, policies and procedures in conjunction with leadership teams
• In conjunction with QA, partner with Clinical Operations Management and Global Learning to define and execute appropriate training interventions
• In conjunction with QA, identify, prioritise, communicate root cause of quality issues and facilitate the creation and execution of appropriate corrective action plans
• Be available as required for all client and Regulatory audits/inspections

Quality Control Evaluation Plan and Quality Control Evaluation Reporting

• Support CTO Management with quality metrics reporting to manage Country Quality Indicators.
• Support Project Management with quality metrics reporting to manage Project Key Quality Indicators.
• Prepare quality control evaluation reports at intervals determined by country and regional management e.g. maintain the Clinical Quality Control (CQC) visit scheduling tracker on an ongoing basis and ensure CQC visit are executed, reported and identified issues are followed up by action owners and resolved within the organizational timelines.

Evaluation of Documentation of Employee Qualifications and Training

• Verify that curriculum vitae, job descriptions, curriculum maps and training records in each country in the respective regions are current and completeness is checked quarterly.

SOPs / Work Instructions / Associated Documents

• Co-ordinate the regional review of new and current SOPs, Work Instruction and Associated Documents for compliance with local regulations and provide necessary feedback to Global SOP Group and the author of the SOP (“global review process”)
• Verify that all personnel complete applicable departmental (SOP) and project training and acknowledge completed training in a timely fashion in the Learning Management System.

Training (in Co-operation with Global Learning and Country/Regional Management)

• Verify that a GCP training matrix/plan is available and current
• Verify that project specific training plan is available and current
• Verify that training is co-ordinated and has been delivered
• Assist with the co-ordination of training when required

Quality Control of Critical Clinical Trial Activities (in Consultation with QA and Operations Management)

• The informed consent process
• Clinical Trial Material control and handling
• Study documentation (essential document filing & IP Package)
• Monitoring
• Data Management/Data Clarification activities
• Statistical Analysis Plans
• AE reporting
• Document Archiving and storage

Ongoing Trend Analysis and Quality Control Improvement Initiatives

• Analyze quality control evaluation trends, identify areas that require remediation and recommend potential activities to correct findings
• Co-ordinate project specific quality control improvement activities
• Assist with the implementation of corrective action
• Escalate significant and/or un-resolved Quality Control findings to management

• Work with QA to co-ordinate Quality Control activities and share information to prevent duplication of effort and findings
• Co-ordinate GCP and SOP-related training within each Covance region
• Perform targeted project specific QC activities within the country offices
• Report on quality control metrics based on adherence to contractual requirements
• Identify, evaluate, and communicate root causes of project specific quality control findings
• Ensure management is aware of issues that will significantly effect project specified activities and provide appropriate solutions

Required:

• University/college degree – life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
• In lieu of this required educational background the following relevant work history may be considered:
  • Minimum of three (3) years supervisory experience in a health care or clinical research setting and
  • Minimum of six (6) years relevant clinical research experience in a pharmaceutical company/CRO

Preferred:

• Masters or other advanced degree

Minimum Required:

• Relevant clinical research experience in a pharmaceutical company or CRO
  • Individual is proficient with on site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits)
  • Minimum of eight (8) years relevant clinical research experience in a pharmaceutical company/CRO
  • Thorough knowledge of drug development process
  • Thorough knowledge of relevant SOPs, ICH, and GCP guidelines
  • Project management, line management experience, and quality control experience highly desirable
• Relevant quality management experience
  • Detailed knowledge of all aspects of GCP guidelines and regulations
  • Demonstrated ability to separate critical from non-critical GCP issues
  • Demonstrated effectively balance quality and speed in complex situations
  • Demonstrated ability to work in a team environment
  • Demonstrated ability to work under pressure and requires minimal supervision
  • Strong interpersonal and communication skills
  • Strong analytical skills
  • Excellent planning and organizational skills
  • Excellent oral, written and presentation skills