Sr Manager, QA Auditor

Job Title: Sr Manager, QA Auditor
Contract Type: Permanent
Location: Shanghai, China
Salary: Negotiable
Reference: 20200812_1592797999
Contact Name: Cherry Zhu
Contact Email:
Job Published: June 22, 2020 11:53

Job Description

Position Title:

Sr Manager. QA Auditor


Quality Assurance

Report To:




Position Summary

Responsible for the initiation, conduct, and follow-up of GCP, GVP, GLP audits as assigned by QA Management. Within the frame of the incumbent's mission and responsibilities, the audits and activities require proven ability to independently interact with all internal (e.g., Projects Teams, Operations…) and external (e.g., Vendors / CRO) operational staff involved in the audited clinical research activities.

Further responsibilities include lead and manage the inspection readiness and inspections. Assisting investigations of Scientific Misconduct and Serious GxP Non-Compliance and the handling of outsourced activities on behalf of CQA, as required and assigned by QA Management.

Key Responsibilities

  • Independently manages and performs routine compliance audits of Clinical Investigator sites for Phase I to IV clinical trials, Systems and CRO /Contract Research Organizations (CRO). Lead routine audits and support complex directed audits. Process Project-related audits include external and/or internal processes such as TMF, CSR, IVRS, central labs, monitoring, data management, filing/archiving, medical writing, statistic etc.
  • As requested by QA management may host during inspections performed by an external partner or regulatory authorities. Support preparation, coordination and communication to management during investigator site, Everest facility inspections. Ensure adequate inspection readiness/preparedness activities in Everest and investigator site. Assist internal team/investigator site/vendor with regulatory authority inspection responses when request.
  • Represents CQA on various project/study team meetings when request. Contribute to quality and continuous improvement at the study/project level. This includes responsibilities such as: - Follow-up on the progress status of assigned project(s).
  • Identifying and analyzing potential issues with an impact on quality; - Contribution to audit planning/programs and assistance in the monitoring of the implementation of those programs; - Participation in the analysis of results of audits for the assigned projects; - Proposing improvements and/or process changes.
  • Coach and mentor junior staff in all aspects of their job performance including training, and disciplinary action.
  • Other tasks assigned by line manager.

Recommended Education and Key Competency

  • Bachelor's Degree in Science, Healthcare or an equivalent, an advanced degree is preferred
  • At least 10 years of experience in the Biotech/Pharmaceutical industry, of which 6 years' experience in a QA/QC role in a GCP GVP environment and 3 years' experience in QA auditor role.
  • Broad Quality Assurance experience and in-depth knowledge of applicable China and worldwide regulatory requirements (e.g. GCP, GVP, GCP, ICH)
  • Proven experience in leading GCP audits and inspections
  • Ability to lead diverse audit teams in evaluation of GxP quality systems
  • Knowledge and experience with risk management programs
  • Works effectively and cooperatively with others - Establishes and maintains good working relationships
  • Excellent project management, communication, management and organizational skills, as well as a high level of proficiency with problem-solving, conflict resolution, negotiation and team-building skills
  • Driven with a strong focus on goals and good teamwork
  • Excellent written and verbal communication skills

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