Covance

Quality Control Manager

Job Location(s) TW-Taipei City
Job Number
2021-70455
Job Category
Quality Assurance
Position Type
Full-Time
Telecommute
No

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
-  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 prestudy,
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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