Kansas Works Jobs

Kansas Works Logo

Job Information

Pfizer Quality Senior Associate in McPherson, Kansas

Role Summary

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.

Role Responsibilities

  • 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

Qualifications

Must-Have

  • 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

Nice-to-Have

  • Bachelor's degree in Microbiology, Chemistry, or related science

  • Experience using USP, EP and other compendia

  • Project management experience

  • Experience with audits and investigations

PHYSICAL/MENTAL REQUIREMENTS

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

#LI-PFE

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.

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.

Quality Assurance and Control

#LI-PFE

DirectEmployers