Quality Associate - Regulatory Change Management

Role Summary

Key contributor to the regulatory process for submission of site changes that impact regulatory filings. This role may be designated a Site Compliance Network Member (SCNM).

Role Responsibilities

• Collaborates with PGS SMEs, PharmSci or other transfer team, PMO and other stakeholders for authoring of Health Authority dossier content.
• Authors and reviews submission content and ensures alignment with Pfizer PQS and Health Authority requirements
• Creates and manages CMC templates specific to the McPherson areas and processes aligned with Pfizer PQS and Health Authority requirements
• Completes impact assessments on site change requests to determine potential for regulatory impact and completes regulatory change requests when impact has been determined. Ensures appropriate supporting documentation and rationale for change is included.
• Utilizes GDMS for authoring activities and support the site in accessing documents in GDMS as needed.
• 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 of 5 years of experience with a combination of Quality Control or Quality Assurance functional area and/or other GxP manufacturing experience
• Proven experience with GxP change management process
• Knowledgeable on ICH process validation and/or method validation, method transfer, and compendial verification
• Technical writing experience
• Working knowledge of regulatory process and requirements for post approval changes
• Good knowledge of English, spoken and written

Nice-to-Have

• Bachelor's Degree in Microbiology, Chemistry or related science
• Experience using USP, EP and other compendia
• Proven experience authoring regulatory submission content

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.

Regulatory Affairs

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