Associate Manager-Quality Investigation

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 ass