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Quality Event Assessment and Investigation Lead (Sr. Manager)


New York, NY
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Job Details

Quality Event Review and Serious Quality Event Identification

As the Quality Event Assessment and Investigation Lead, this individual will be accountable for the review and classification of submitted quality issues to ascertain if the SQE threshold has been met. He or she will ensure that each submitted issue is reviewed based on the established criteria, is categorized appropriately and completed within

the required time frame to ensure that events are appropriately qualified enabling expedited investigation where necessary. This individual will be responsible for completing the necessary documentation in the quality event assessment system (QUEST) regarding the assessment of the submitted events.

Quality Event Investigation

Once assigned a qualified event (SQE), the individual 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.

Quality Event Assessment and Investigation Lead will be responsible for

Triage submitted cases to ascertain if the Significant Quality Event (SQE) threshold has been met and assess cases to determine if they need expedited reporting to senior management and/or regulatory authorities.

Drive SQE case management for assigned cases, including the investigation/root cause analysis, corrective/preventive action (CAPA) plan development, implementation of assigned plan components and tracking of actions to completion.

Basic 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

. Ability to travel ~20%.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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