EG-Sr. Manager, Clinical Quality Management

EG-Sr. Manager, Clinical Quality Management

Pfizer Asia Pacific Pte Ltd
Shanghai China
10-13 years
Not Specified

Job Description


Job Description :
Job Description
Main Responsibility
  • Once assigned a qualified event (SQE), the Quality Event Investigation Lead will initiate the investigation of the event to confirm the chronology and details of the issue.
  • Investigation will include reviewing relevant SOPs and supporting documents to understand what should have happened per our documented process and identifying what did not happen per the process.
  • In addition, the investigation will include review of relevant documentation re: the event and assembling the SQE team with appropriate stakeholders (SME's, study team members, etc) to review and confirm the details of the event.
  • Root Cause Analysis/Due Diligence
    This individual will also be required to apply a root cause methodology and/or due diligence approach to the case.
  • The individual will be trained in the application of an appropriate methodology and will apply it as part of the management of the case.
  • CAPA Plan Development
    Based on identified root causes, the individual will guide the SQE team in identifying appropriate corrective and preventive actions and conducting effectiveness checks on implemented actions to ensure they are working as expected.

Qualifications:
  • BS-10 years or equivalent
  • MS/MBS – 5 years or equivalent
  • Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory.
  • Regulatory inspection experience
  • Process and system management experience
  • Detailed knowledge of clinical trial processes and relationships required
  • Knowledge of GCP requirements and applicable SOPs and regulations
  • Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills
  • Strong background in continuous improvement methodology (ie Lean Six Sigma) preferred

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and Control

Job Details

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IT

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

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