Associate Manager-Quality Investigation

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.  

• →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.

• 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.

• 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.

• 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

• 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

• 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.

• Focus on what matters most.
• Measure outcomes and drive continuous improvement.
• Demonstrate scientific rigor in decision making.
• Promote a right-first-time investigation culture.

• Speak up and challenge unsupported conclusions.
• Make quality-based decisions using facts and data.

• Demonstrate objectivity, fairness, and consistency in investigation reviews.

• Foster collaboration, knowledge sharing, and continuous learning.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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