Covance

  • Quality Control Mgr, Proj Mgt

    Job Location(s) UA
    Job Number
    2018-21920
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    • Responsibility for the annual country specific QC plan, monitoring, and coordinating the implementation, and execution of QC plan in the respective country/US region according to the Client Standard Operating Procedures and ICH Guidelines and GCP
    • Responsibility for the management of the Client Corrective and Preventive actions (CAPA) of GCP audits and inspections in the country/US region at the Client level according to the Client Standard Operating Procedures and ICH Guidelines and GCP
    • Responsibility for the annual country specific quality plan, monitoring, and coordinating the implementation and execution of QC in the respective country/region
    • Responsibility to manage and/or co-lead key Client initiative charged with executing the continuous improvement
    • CCQM identifies local as well as global process improvement opportunities and training needs, and will be the local point of contact for all stakeholders ensuring appropriate training is implemented
    • The role requires the ability to follow current processes and procedures of the Client but also the ability to improve processes and procedures
    • This position has a significant impact on the ability to conduct clinical trials in accordance with external and internal regulations and guidelines of the Client

    On the Client level:               

    • ICH Guidance and GCP Regulations, Country Client SOPs: Is an expert at local level
    • Local Lead for Management of the Client Country Standard Operation Procedures (CSOP)
    • In cooperation with country functional area heads: ensures the Client CSOPs are checked /updated regularly; signs/authorizes CSOP deviations along with process owner
    • Responsible for all aspects of the quality site management as prescribed in the project plans
    • Local Quality and Process Improvement and training contact person- identifies local training demand, initiate local training needs and activities
    • Defines an annual country QC plan with collaboration to regional CQM
    • With mutual agreement with the functional areas will perform quality control (QC) activities and visits. Support on resolution of quality issues
    • Responsible for management and support audit preparation activities. In cooperation with country functional area person initiate state of the art root cause analysis for audit and inspection findings
    • Responsible for country trend analysis and impact assessments of audits and/or inspection findings

    Education / Qualifications

    • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
    • In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered
    • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
    • Thorough understanding of the drug development process
    • Fluent in local office language and in English, both written and verbal

    Experience

    • Minimum of six-eight (6-8) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
    • Deep knowledge and understanding of Clinical Trial processes and quality management tools
    • Demonstrated experience leading cross-functional teams of business professional
    • Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results
    • Excellent site monitoring skills
    • Excellent study site management skills
    • Ability to work with minimal supervision
    • Good planning and organization skills
    • Good computer skills with good working knowledge of a range of computer packages
    • Excellent verbal and written communication skills
    • Ability to train and supervise junior staff
    • Ability to resolve project-related problems and prioritizes workload for self and team
    • Ability to work within a project team
    • Works efficiently and effectively in a matrix environment.

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