1+ months

EG - Sr. Manager, Clinical Quality Management

Pfizer
Hedgesville, WV 25427
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**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 DiligenceThis 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 DevelopmentBased 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



\#LI-PFE



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
Posted: 2021-01-18 Expires: 2021-07-15
Sponsored by:
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EG - Sr. Manager, Clinical Quality Management

Pfizer
Hedgesville, WV 25427

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