Pfizer Quality Senior Associate in McPherson, Kansas
Manages regulatory process for submission of site changes that impact regulatory filings. The role may be designated a Site Compliance Network Member (SCNM). Works with change owners to develop robust change implementation strategy with aim of minimizing impact to product supply.
Manages regulatory submission aspects of major site changes such as changes impacting multiple products, major facility changes, or new products to ensure regulatory activities are on schedule to meet regulatory commitments and supply requirements.
Tracks changes with regulatory impact from initiation through submission to implementation and manages product holds for pending market activities.
Coordinates submission activities with PGS SMEs, PharmSci or other transfer teams, PMO, and other stakeholders to ensure all activities are completed on schedule to meet regulatory commitments and supply requirements in the context of competing priorities and deadlines.
Liaises with supply organization to identify key products/markets to mitigate supply constraints related to individual health authority approval of site changes
Manages site regulatory submission peer review and query response activities and ensures content is robust with documentation and rationale that supports the change.
Completes Impact assessments on requested site Change Requests to determine potential for regulatory impact
Completes appropriate regulatory change requests when impact has been determined. Ensures appropriate supporting documentation and rationale for change is included.
Creates and manages CMC templates specific to McPherson areas and processes aligned with Pfizer PQS and Health Authority requirements
Serves as subject matter expert related to submission process and supports the site understanding and interpreting requirements.
Supports other site Quality functions such as annual product record review, etc. as assigned
Bachelor's Degree in Science, Engineering, or Business
A minimum 7 years of prior experience with a combination of Quality Control or Quality Assurance functional area and/or other GxP manufacturing experience
Working knowledge of GxP change management process
Knowledge of ICH process validation and method validation requirements
Knowledge of regulatory requirements for post approval changes
Technical writing and editing experience
Bachelor's degree in Microbiology, Chemistry, or related science
Experience using USP, EP and other compendia
Project management experience
Experience with audits and investigations
Sitting, standing, walking, ability to perform mathematical calculations, and ability to perform complex data analysis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Remote, onsite, or flex schedule.
Core business hours 8-5, occasional evening, weekend, and holiday work may be required.
No routine Travel, occasional Travel 0-10%.
Other Job Details:
Last Date to Apply for Job: October 25, 2021
Eligible for Employee Referral Bonus: Yes
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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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.
Quality Assurance and Control