1+ months

Sr.Mgr, Clinical Quality Mgmt

Pfizer
Hedgesville, WV 25427
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

Previous Experience:

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

N: Not Applicable - (China)

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

Categories

Posted: 2019-06-25 Expires: 2019-11-08

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Sr.Mgr, Clinical Quality Mgmt

Pfizer
Hedgesville, WV 25427

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