Quality Compliance Associate Director – Aseptic Processing

🕒 Junho 13

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $145.241 - $196.502 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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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 aseptic processing and contamination control subject matter expert for Quality Compliance, 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 aseptic processing 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 technologies, practices, and contamination control tools. • Contribute to Global Aseptic Council 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 aseptic processing -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 aseptic processes, 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. • 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. • 3 years of experience in aseptic processing, leading, environmental monitoring programs, or contamination control technical workstreams. • Strong technical knowledge of aseptic processing, 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 manufacturing technologies, rapid microbiological methods, automation, data trending tools, or contamination control improvements. • Demonstrated ability to lead cross-functional teams, influence without direct authority, communicate complex technical information clearly, and manage multiple priorities. • Ability to work effectively with global and virtual teams across time zones while adapting approaches based on technical complexity, regulatory considerations, and stakeholder needs. • Effective English written and verbal communication skills; additional language capability is a plus. • Ability to travel domestically and internationally up to 20% of the time.

🏖️ 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, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.