Mexico Job Openings
Pfizer
Issue Lead
New York
FULL TIME
September 18, 2024
ROLE SUMMARY:
The Issue Lead will be responsible for driving Quality Event (QE) case management, ensuring that investigations are conducted thoroughly within timelines and compliance requirements, overseeing the efficiency of the process by which Pfizer conducts GCP investigations, and leveraging data to assess the efficiency / performance of the appropriate teams to perform interventions as needed.
The Issue Lead will also triage submitted cases to ascertain if the QE threshold has been met and assess cases to determine if they need expedited reporting to senior management and/regulatory authorities be accountable for managing confirmed QE case through the investigation process including root cause analysis.
ROLE RESPONSIBILITIES:
Quality Event Assessment and Investigation
This individual will be accountable for the review and classification of submitted quality issues to ascertain if the QE 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 also be responsible for completing the necessary documentation in the e QMS system regarding the assessment of the submitted events.
Notification to Management
This individual will be responsible for initiating appropriate escalation of Critical QEs when necessary, ensuring that management is promptly and appropriately informed of quality events. The Issue Leads will be required to assess critical issues and identify these items as appropriate for escalation to leadership via the Notification to Management process.
Root Cause Analysis / Gap Analysis / Due Diligence
Once assigned a QE, the Issue Lead will initiate the investigation of the event to confirm the chronology and details of the issue. This individual will also be required to apply a root cause analysis, gap analysis, and / or due diligence investigation 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. 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 QE team with appropriate stakeholders (SME's, study team members, etc.) to review and confirm the details of the event.
Process Analysis and Improvement
This individual will be responsible for contributing to process development and improvement for case management including contributing to the development of technology (in collaboration with PFE Digital) to enable the process. In addition, the individual, along with Senior Issue Lead peers, will develop and implement guidance documents and training to assist the investigation leads in completing cases to expectations.
CAPA Plan Development and Management
This individual will hold accountability for ongoing monitoring of CAPA completion and tracking of effectiveness for implemented mitigation actions to ensure they are working as expected—for quality events, inspections and audits.
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Ensure implementation of QE / audit / inspection CAPAs and remediation plans
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Track effectiveness checks and report on trends
Risk Mitigation Tracking
Track and ensure implementation of IQMP risk mitigations
Evaluate potential impacts to business
BASIC QUALIFICATIONS:
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BS – 7+ years or equivalent
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MS/MBA – 6+ years or equivalent
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Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, Gx P Quality, and/or regulatory
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Regulatory inspection experience
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Process and system management experience
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Detailed knowledge of clinical trial processes and relationships required
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Knowledge of GCP requirements and applicable SOPs and regulations
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Project management, administrative, and technical capabilities are required, as well as effective verbal communication skills
PREFERRED QUALIFICATIONS:
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Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred
Other Job Details:
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Last Day To Apply: October 1, 2024
Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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