What are the responsibilities and job description for the Oncology Asset Quality Lead position at BioCT Innovation Commons?
Job Summary :
Driving Level One quality for assets within one or multiple Oncology Franchise / tumor types by maintaining ‘quality’ line-of-sight for assets / protocols within the Pfizer Oncology clinical portfolio.
Find out more about this role by reading the information below, then apply to be considered.
The Asset Quality Lead (AQL) role brings deep knowledge of Level One quality issues and risk areas within assets and across clinical trial programs. In partnership with the appropriate roles in Clinical Development & Operations, the AQL will work with Clinical Study Team Quality Leads within their assets to ensure asset and study level quality oversight, drive quality risk management activities across an asset, and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS.
They will be the initial escalation point for stakeholders and asset teams for asset and study quality risk management, quality issues management, and general GCP guidance.
Job Responsibilities :
Level 1 GCP Quality :
- IQMP (Integrated Quality Management Plan) Development and Oversight at disease area and program level including integration within the Quality Management System (QMS) and ensuring individual asset and study level IQMPs are in place.
- Escalation, Communication, and Governance – work within the Pfizer QMS framework, and in collaboration with PRD Quality, to ensure quality issues are escalated from study-level Asset Quality Leads and addressed appropriately. Represent their disease area / sub-portfolio within Pfizer Oncology Quality governance processes / meetings.
- Inspection Readiness and Preparation, CAPA management – work within the Pfizer QMS framework, and in collaboration with PRD Quality to ensure inspection readiness and management of CAPAs.
Other Responsibilities :
Basic Qualifications :
Bachelors – 8 years or equivalent
Preferred Qualifications :
Work Location Assignment : Hybrid
The annual base salary for this position ranges from $156,600.00 to $261,000.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% 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.
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.
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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Salary : $156,600 - $261,000