Covance Quality Control Mgr, Proj Mgt in Ukraine

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.

Job Number 2018-21920

Job Category Clinical Operations

Position Type Full-Time

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