Associate Manager-Quality Investigation

About This Opportunity

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Full source description

• Use Your Power for Purpose Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients
• Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented
• Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients
•   Key Responsibility Independently review and challenge microbiological deviation, OOS/OOT, contamination, environmental monitoring (EM) excursion, sterility assurance, and objectionable organism investigations to ensure scientific robustness and regulatory compliance
• Evaluate investigation strategy, data integrity, and adequacy of evidence to ensure conclusions are supported by facts and scientific rationale
• Drive effective root cause analysis utilizing structured investigation tools such as 5-Why, Fishbone Analysis, Fault Tree Analysis, and Human Error Reduction techniques
• Assess product, process, patient, and compliance risks and ensure appropriate risk mitigation measures are identified and implemented
• Review and challenge proposed CAPAs to ensure they address the true root cause and are capable of preventing recurrence
• Ensure investigations comply with cGMP requirements, internal quality standards, and regulatory expectations from FDA, EMA, MHRA, PIC/S, and WHO
• Partner with Microbiology, Manufacturing, Engineering, Technical Services, Validation, and Quality teams to strengthen investigation effectiveness and quality culture
• Coach investigation owners on scientific reasoning, critical thinking, technical writing, and investigation best practices
• Identify recurring trends, systemic gaps, and opportunities for continuous improvement within microbiological quality systems
• Support contamination control strategies and continuous improvement initiatives related to aseptic processing and sterility assurance
• Key Deliverables Timely closure of microbiological investigations without compromising investigation quality
• Improved effectiveness and depth of root cause analysis
• Reduction in repeat deviations and recurring contamination-related events
• Enhanced quality and regulatory compliance of investigation reports
• Improved CAPA effectiveness and sustainability
• Strengthened contamination control and sterility assurance practices
• Increased capability of site personnel in performing scientifically sound investigations
• Improved inspection readiness and reduction in regulatory observations related to investigation quality
• Development of a robust knowledge base for microbiology-related quality events and lessons learned
• Education Qualification B.Pharm, M.Pharm, M.Sc
• Microbiology, Biotechnology, Pharmaceutical Sciences, or related discipline
• 6+ years of experience in sterile pharmaceutical manufacturing, microbiology, quality assurance, or investigation management
• Required Skills Quality Assurance Quality Management Systems (QMS) Microbiological Investigations Root Cause Analysis Risk Management Data Integrity Regulatory Compliance (FDA, EMA, MHRA, PIC/S) Technical Report Review and Approval Transferable Skills to Develop Critical Thinking and Scientific Decision Making Investigative Interviewing Techniques Risk-Based Assessment and Prioritization Data Analysis and Trend Evaluation Technical Writing and Report Critique Influencing Without Authority Problem Solving and Systems Thinking Stakeholder Management Effective Communication and Coaching Key Investigator & Reviewer Competencies Ability to distinguish symptoms from true root causes
• Ability to challenge assumptions and identify investigation gaps
• Strong analytical mindset with attention to detail
• Capability to assess investigation completeness and scientific soundness
• Ability to identify bias and ensure fact-based decision making
• Strong understanding of human performance and human error reduction concepts
• Effective questioning and interviewing skills to obtain factual information
• Capability to evaluate product quality impact and patient risk objectively
• Values/Behaviours to Develop Excellence Focus on what matters most
• Measure outcomes and drive continuous improvement
• Demonstrate scientific rigor in decision making
• Promote a right-first-time investigation culture
• Courage Speak up and challenge unsupported conclusions
• Make quality-based decisions using facts and data
• Equity Demonstrate objectivity, fairness, and consistency in investigation reviews
• Joy Foster collaboration, knowledge sharing, and continuous learning
•   Work Location Assignment: On Premise Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates
• To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers
•     Quality Assurance and Control

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