Associate Director, Quality Compliance – Microbiology

🕒 il y a 12 jours

🇺🇸 États-Unis – Télétravail

💵 $145 241 - $196 502 / an

⏰ Temps Plein

🟠 Senior

🚔 Conformité

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

Postuler Maintenant

Trouver des Emplois à Distance Similaires

Recevoir des emails pour des emplois à distance

📊 Vérifiez votre score de CV pour ce poste

Améliorez vos chances d'obtenir un entretien en vérifiant votre score de CV avant de postuler.

Télécharger le CV

Amgen

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1980

🧬 Biotechnologie

💊 Pharmaceutique

🔬 Science

💰 €28 500 000 000 Post-IPO Debt en 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen est un leader mondial de la biotechnologie, se concentrant sur le développement et la commercialisation de médicaments innovants issus de cellules vivantes. L'entreprise vise à traiter des maladies graves, ciblant souvent des affections avec peu d'options thérapeutiques. Amgen met l'accent sur l'innovation scientifique et s'engage dans la recherche éthique, la sécurité des patients et le développement durable. Elle participe activement aux essais cliniques et est reconnue pour ses contributions dans les domaines du traitement du cancer et de la gestion de l'obésité, entre autres.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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.