Job Description

What You Will Achieve

As a Quality Event Investigation Lead, you will be accountable for managing confirmed Significant Quality Event (SQE) case through the investigation process including root cause analysis. The Quality Event Investigation Lead will ensure the investigations are conducted thoroughly, within required timelines and to compliance requirements including ensuring the adequacy of root cause analysis and appropriateness of communication regarding the case. The Quality Event Investigation Lead will lead the SQE team in the development of appropriate Corrective and Preventative Actions (CAPA) and assign completion dates to action owners that ensure actions are progressed quickly to completion.

How You Will Achieve It

Significant Quality Event Investigations
You will ensure that each confirmed case is investigated appropriately including ensuring investigation timelines are met and that appropriate pre-work is done on the case the enable an investigation with appropriate quality outcomes including a well written case summary (meets defined quality standards) which can be used in a regulatory inspection. Case summaries should not require more than a single round of review by an approver.

Case documentation will be complete and accurate and filed as necessary to ensure inspection readiness. You will appropriately escalate concerns regarding the progress of a case or a SQE teams resistance to the implementation of appropriate CAPAs so that it can be addressed and resolved in a timely manner

The Quality Event Investigation Lead will be responsible for managing all extension requests for cases, actions and CAPA effectiveness checks so that approvers are given adequate time to approve before the case goes overdue.
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

Eligible for Employee Referral Bonus: YES

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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 providers 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.

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.

Medical

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