Pfizer

Quality Event Assessment and Investigation Lead (Sr. Manager)

Employer
Pfizer
Location
Collegeville, Pennsylvania; Groton, Connecticut
Salary
Competitive
Posted
July 14 2021
Ref
4819069
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager
As part of the Clinical Quality Team you will be responsible for the assessment and investigation (including root cause analysis and inspection readiness documentation) of GCP quality events a cross the Clinical Development Portfolio .

The Quality Event Investigation Lead 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.

Serious Quality Event Investigation

He or she 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. He

or she 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 · PhD/MD - 3 years or equivalent Previous Experience: · Minimum of 10 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory. · Regulatory inspection experience · Detailed knowledge of clinical trial processes and relationships required · Knowledge of GCP requirements and applicable SOPs and regulations · Project management, resource management (staff and financial), administrative, and technical capabilities are required, as well as effective verbal and written communication skills · Strong scientific background in Life Sciences, Regulatory Affairs, or higher degree preferred.

Last Date to Apply for Job: 7/27/2021

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 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.

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.

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