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 eQMS 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.
Risk Mitigation Tracking
Track and ensure implementation of IQMP risk mitigations
Evaluate potential impacts to business
BASIC QUALIFICATIONS:
PREFERRED QUALIFICATIONS:
Other Job Details:
The annual base salary for this position ranges from $109,400.00 to $182,300.00.* In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
* The annual base salary for this position in Tampa, FL ranges from $98,400.00 to $164,000.00.
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.
Medical
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Salk Institute for Biological Studies |
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Salk Institute for Biological Studies |
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Salk Institute for Biological Studies |