Covance

  • Sr Mgr Regional Qual Control

    Job Location(s) CN-Beijing
    Job Number
    2019-35632
    Job Category
    Clinical Operations Management
    Position Type
    Full-Time
  • Job Overview

    Reporting to the Associate Director, Regional Quality Control or above, this Senior Manager, Regional Quality Control (SMRQC) position will work primarily with Clinical Operation, Clinical Team Leads, and Project Management and with other Functions as appropriate to ensure that the contract specified activities conducted by these departments meets or exceeds all obligations defined by the project contract.  In addition, this individual will work with the Country Leadership and Senior Management, to report on and assist with the correction of Quality Control or observed project process deficiencies noted by the SMRQC during Quality Control evaluations.  The individual will also work with the global and regional QA Heads to ensure a common understanding of quality issues and execution of quality strategies. In all of the above, the SMRQC will verify that the Functional Heads, Country Leads and Regional Leads have in place appropriate Quality Plans and measures.

    As part of their role, the SMRQC will:

    • Provide guidance to the Country Leaders 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 coordinate 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

     

    1. Responsibilities / Duties:

     

    • Responsibility for the oversight of QC activities relating to GCP Compliance and Quality Management (QM) within their countries and in global alignment. This includes (but is not limited to), ensuring adherence and compliance with the process, identification and escalation of quality issues and monitoring the creation and execution of preventative and corrective action plans
    • Use an annual quality plan including a process to collect, analyse and report on quality metrics across the regional business
    • In cooperation with other regional QA Managers and Senior Management, ensure the collection of appropriate metrics and tracking systems to facilitate a proactive, risk based quality management approach.
    • Co-Chair the regional ‘Quality Improvement Team (QIT) meeting.
    • Communicate the business case to support recommendations for quality control / quality management change to current business practices and processes
    • 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
    • As requested, work with Operational and QA personnel to ensure completion and resolution of Client and Quality Assurance audit findings, Corrective Action and Preventive Action (CAPA) plans, and Confirmed Quality Issues (CQI’s 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 Global Learning and Development (L&D) 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

     

     

    SOPs / Work Instructions / Associated Documents

     

    • Support the regional review of new and current SOPs, Work Instructions, Associated Documents and country-specific processes as applicable for compliance with local regulations and provide necessary feedback to Global SOP Group and the author of the SOP (“global review process”)
    • Through QC metrics reporting, verify that all personnel complete SOP review acknowledgments and that the acknowledgments are properly archived

     

     

     

    Training (in Co-operation with L&D and Country/Regional Management)

     

    • Through QC metrics reporting, verify that functional training has been completed by assigned staff
    • Through QC metrics reporting, verify that training is co-ordinated and has been delivered
    • Assist with the coordination of quality control training when required

     

     

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

     

    Through the conduct of Quality Control evaluations ensure GCP/SOP/Project Specific Plans implementation for:

     

    Informed consent process

    Clinical Trial Material control and handling

    Study documentation (essential document filing & IP Package)

    Monitoring reporting

    Data Management/Data Clarification activities

    Safety / AE reporting

    Study Conduct / Procedures

    IRB/IEC documentation

    Data Privacy / Protection of subject rights

    Project Management

    Site personnel assignment, qualifications and training

    Facilities and equipment

     

    Escalate quality risks identified during CQC activities to project teams and QA per SOP requirements.

     

     

    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
    • Coordinate project specific quality control improvement activities
    • Assist with the implementation of corrective action
    • Escalate significant and/or unresolved Quality Control findings to management

     

     

    Other Key Responsibilities:

     

    • Work with QA to co-ordinate Quality Control activities and share information to prevent duplication of effort and findings
    • Support GCP and SOP-related training within each Covance region
    • As necessary, support targeted project specific QC activities within the country offices
    • Prepare and report on quality control metrics based on adherence to contractual requirements, ICH/GCP and Covance SOPs.
    • Identify, evaluate, and communicate root causes of quality control deficiencies
    • Ensure management is aware of issues that will significantly affect compliance and support the development of appropriate solutions.

    Education/Qualifications

    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

    Experience

    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

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