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Head of Asia Clinical Quality Assurance

Job Title: Head of Asia Clinical Quality Assurance
Contract Type: Permanent
Location: Shanghai, China
Industry:
Salary: Negotiable
Reference: 20200808_1584093681
Contact Name: Cherry Zhu
Contact Email: czhu@profileasia.com
Job Published: March 13, 2020 18:01

Job Description

 

ACCOUNTABILITIES:

  • Leads the Asia CQA functions in the development, implementation, and refinement of processes to ensure that maintains sponsor oversight of the quality of its development activities in compliance with applicable regulatory requirements.
  • Collaborates with the Head of R&D Clinical Quality Assurance to develop and implement the strategy for sponsor quality oversight of development activities in Asia.
  • Analyzes audit and compliance metrics to identify risks and evaluate the state of GCP compliance; presents analyses to TDC Asia leadership and Quality leadership and provides guidance for key stakeholders to make critical decisions
  • This position has responsibility for the CQA hiring, ongoing development and operational success of the CQA function in Asia, including talent development and succession planning, resourcing and budgeting.
  • Provides leadership for investigation of critical compliance issues (scientific misconduct and serious breach) and escalates as appropriate to internal and external partners, including regulators, as appropriate
  • Escalates systemic problems and appropriate recommendations/solutions to senior leadership for immediate and long-term resolution across R&D
  • Provides strategic direction and manages health authority GCP sponsor and investigator routine and pre-approval inspection readiness, conduct, and follow-up activities for development programs in Asia, ensuring that GCP inspection commitments are fulfilled on time
  • Collaborates with GCP Supplier Quality to evaluate the acceptability of vendors for potential use by R&D as well ongoing evaluation of overall compliance performance of vendors
  • Ensures strong alignment with other R&D Quality and relevant R&D functions.

 

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BS/BA Degree required; advanced degree preferred
  • Minimum 7 years managing teams in a matrix team environment or managing people.
  • Minimum 12 years of industry experience in QA and/or Clinical Operations; advanced experience in GCP auditing preferred