Associate Director, Quality Compliance – Microbiology

🕒 Junho 13

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $145.241 - $196.502 / ano

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Biotechnology • Pharmaceuticals • Science

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• Serve as a microbiology and contamination control subject matter expert for Quality Compliance, QC laboratories, manufacturing, and site teams. • Support the contamination control program, including site engagement, network participation, metrics review, risk identification, and escalation of significant concerns. • Contribute to the development, revision, and implementation of global microbiology and contamination control standards, procedures, technical guidance, and quality intelligence documents. • Support periodic contamination control reviews, trend evaluations, and state-of-control assessments for in-scope sites, processes, and products. • Provide technical input for environmental monitoring, bioburden control, endotoxin, microbial identification, disinfectant efficacy, cleaning and disinfection, gowning, aseptic practices, utilities, facilities, and laboratory controls. • Partner with site Quality, Manufacturing, Engineering, and QC laboratories to promote consistent application of contamination control expectations. • Provide technical review and recommendations for microbiology investigations, deviations, CAPAs, risk assessments, change controls, audit observations, and inspection commitments. • Support evaluation and implementation of new or improved microbiology methods, technologies, laboratory practices, and contamination control tools. • Contribute to Microbiology Center of Excellence activities, technical forums, communities of practice, and network alignment discussions. • Support regulatory inspections, internal audits, health authority commitments, and inspection-readiness activities related to microbiology, contamination control, QC laboratories, and manufacturing controls. • Provide technical input to audit responses, regulatory inspection responses, CAPA plans, and effectiveness checks. • Review regulatory filings, responses, or technical documents for microbiology-related content, as assigned. • Monitor relevant regulatory, compendial, and industry developments and help translate them into practical expectations for sites and functions. • Lead or support cross-functional projects related to microbiology, contamination control, laboratory practices, inspection readiness, or quality improvement.

🎯 Requisitos

• Doctorate degree and 3 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience OR Master’s degree and 7 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience OR Bachelor’s degree and 9 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience OR Associate’s degree and 12 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience OR High school diploma / GED and 14 years of Quality, Microbiology, Manufacturing, or relevant regulated industry experience • Minimum of 3 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. • Preferred Qualifications: Life Science, Microbiology, Biology, Biological Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, or related scientific academic background. • 8+ years of experience in Quality, QC microbiology, Manufacturing, contamination control, sterility assurance, or a related GMP function within the biotechnology or pharmaceutical industry. • Strong technical knowledge of microbiology and contamination control practices, including environmental monitoring, bioburden, endotoxin, microbial identification, disinfectant efficacy, cleaning and disinfection, gowning, aseptic practices, utilities, facilities, and laboratory controls. • Experience supporting GMP investigations, deviations, CAPAs, change controls, risk assessments, audits, inspection readiness, or regulatory inspection activities. • Experience in biologics, sterile manufacturing, aseptic processing, drug substance manufacturing, drug product manufacturing, or QC microbiology laboratory operations. • Experience contributing to global or multi-site standards, procedures, technical guidance, training materials, quality intelligence, or quality system improvements. • Ability to interpret and apply GMP, GxP, regulatory, compendial, and industry expectations to microbiology, manufacturing, Quality Control, and contamination control processes. • Experience supporting or participating in technical networks, communities of practice, Centers of Excellence, or cross-site microbiology forums. • Experience evaluating or implementing new microbiology technologies, rapid microbiological methods, laboratory automation, data trending tools, or contamination control improvements. • Ability to work effectively with global and virtual teams across time zones while adapting approaches based on technical complexity, regulatory considerations, and stakeholder needs.

🏖️ Benefícios

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • group medical, dental and vision coverage • life and disability insurance • flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.