{"id":3450517,"url":"https://alion.io/job/pfizer-associate-manager-quality-investigation","title":"Associate Manager-Quality Investigation","company":{"id":3480,"name":"Pfizer","domain":"pfizer.com","url":"https://alion.io/company/pfizer","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":87,"open_postings":25,"ghost_share":0,"stale_share":0.72,"repost_share":0,"time_to_fill_p50_days":13,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Management","role_family":"Management","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Visakhapatnam, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":10500,"max_usd":25000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":15},"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-29T10:43:49Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-10-31T21:54:27Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Use Your Power for Purpose\nEvery 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.\nKey Responsibility\nIndependently 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.\nEvaluate investigation strategy, data integrity, and adequacy of evidence to ensure conclusions are supported by facts and scientific rationale.\nDrive effective root cause analysis utilizing structured investigation tools such as 5-Why, Fishbone Analysis, Fault Tree Analysis, and Human Error Reduction techniques.\nAssess product, process, patient, and compliance risks and ensure appropriate risk mitigation measures are identified and implemented.\nReview and challenge proposed CAPAs to ensure they address the true root cause and are capable of preventing recurrence.\nEnsure investigations comply with cGMP requirements, internal quality standards, and regulatory expectations from FDA, EMA, MHRA, PIC/S, and WHO.\nPartner with Microbiology, Manufacturing, Engineering, Technical Services, Validation, and Quality teams to strengthen investigation effectiveness and quality culture.\nCoach investigation owners on scientific reasoning, critical thinking, technical writing, and investigation best practices.\nIdentify recurring trends, systemic gaps, and opportunities for continuous improvement within microbiological quality systems.\nSupport contamination control strategies and continuous improvement initiatives related to aseptic processing and sterility assurance.\nKey Deliverables\nTimely closure of microbiological investigations without compromising investigation quality.\nImproved effectiveness and depth of root cause analysis.\nReduction in repeat deviations and recurring contamination-related events.\nEnhanced quality and regulatory compliance of investigation reports.\nImproved CAPA effectiveness and sustainability.\nStrengthened contamination control and sterility assurance practices.\nIncreased capability of site personnel in performing scientifically sound investigations.\nImproved inspection readiness and reduction in regulatory observations related to investigation quality.\nDevelopment of a robust knowledge base for microbiology-related quality events and lessons learned.\nEducation Qualification\nB.Pharm, M.Pharm, M.Sc. Microbiology, Biotechnology, Pharmaceutical Sciences, or related discipline.\n6+ years of experience in sterile pharmaceutical manufacturing, microbiology, quality assurance, or investigation management.\nRequired Skills\nQuality Assurance\nQuality Management Systems (QMS)\nMicrobiological Investigations\nRoot Cause Analysis\nRisk Management\nData Integrity\nRegulatory Compliance (FDA, EMA, MHRA, PIC/S)\nTechnical Report Review and Approval\nTransferable Skills to Develop\nCritical Thinking and Scientific Decision Making\nInvestigative Interviewing Techniques\nRisk-Based Assessment and Prioritization\nData Analysis and Trend Evaluation\nTechnical Writing and Report Critique\nInfluencing Without Authority\nProblem Solving and Systems Thinking\nStakeholder Management\nEffective Communication and Coaching\nKey Investigator & Reviewer Competencies\nAbility to distinguish symptoms from true root causes.\nAbility to challenge assumptions and identify investigation gaps.\nStrong analytical mindset with attention to detail.\nCapability to assess investigation completeness and scientific soundness.\nAbility to identify bias and ensure fact-based decision making.\nStrong understanding of human performance and human error reduction concepts.\nEffective questioning and interviewing skills to obtain factual information.\nCapability to evaluate product quality impact and patient risk objectively.\nValues/Behaviours to Develop\nExcellence\nFocus on what matters most.\nMeasure outcomes and drive continuous improvement.\nDemonstrate scientific rigor in decision making.\nPromote a right-first-time investigation culture.\nCourage\nSpeak up and challenge unsupported conclusions.\nMake quality-based decisions using facts and data.\nEquity\nDemonstrate objectivity, fairness, and consistency in investigation reviews.\nJoy\nFoster collaboration, knowledge sharing, and continuous learning.\nWork Location Assignment: On Premise\nPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.\nTo learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.\nQuality Assurance and Control","description_format":"text","description_chars":5000,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Continuous learning","Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Infectious Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-29T10:43:49Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely 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