Senior Quality Assurance Associate, Quality Risk Management
PfizerAbout the role
Use Your Power for Purpose
Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.
The Senior Quality Associate, QRM is responsible for quality assurance in relation to Quality Risk Management program. The role interfaces heavily with site personnel that are completing activities quality risk management including the site quality risk register. The role is engaged in site processes and projects at varying levels, acting as the quality oversight in the quality risk management processes ensuring compliance with procedure and compliance requirements.
What You Will Achieve
In this role, you will:
Responsible for SME strategic review and evaluation of quality risk assessments and potential risks that impact the McPherson plant including complex projects/risk assessments
Monitors quality system metrics and executes actions to ensure quality system performance.
Provide support and act as liaison to business units, corporate, and stakeholders for quality risk management process including updates to quality risk register.
Serve as the McPherson site resource for quality risk management, ensuring compliance/procedural requirements are met.
Acts as quality authority for quality risk management.
Identify and act on improvement opportunities for quality risk management processes
Able to support other quality functions.
Here Is What You Need (Minimum Requirements)
Applicant must have a high school diploma and eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience.
Understanding of code of federal regulations around cGMP and medical devices (21 CFR Part 210, 211, 820).
Experience in quality, production and/or production systems in a GMP regulated environment.
Ability to coach peers in quality management systems.
Good verbal, written and interpersonal communication skills.
Proficient computer skills in Microsoft (MS) Word, Excel and PowerPoint required. Experience with electronic quality systems preferred.
Bonus Points If You Have (Preferred Requirements)
Strong relationship management, communication and presentation skills.
Experience with quality risk management including risk register management.
Strong verbal, written and interpersonal communication skills.
Strong understanding of quality risk management principles and applications.
Experience with quality risk management including risk register management.
Experience with using Veeva quality management systems, i.e. eQMS or similar software.
PHYSICAL/MENTAL REQUIREMENTS
Evaluating and reviewing electronic documents
Office environment with some production floor interaction (minimal)
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Be able to support 24/7 manufacturing site
Work Location Assignment: On-site
OTHER JOB DETAILS
Last Date to Apply for Job: April 6, 2026.
Referral Bonus Eligibility: YES
Eligible for Relocation Package: YES
Relocation assistance may be available based on business needs and/or eligibility.
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