Quality Compliance - Associate Director - Microbiology

Amgen • Thousand Oaks, CA

2d • $145,241 - $196,503 • Remote

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Quality Compliance Associate Director - Microbiology What you will do Let’s do this. Let’s change the world. In this vital role, you will serve as a Quality Compliance microbiology subject matter expert supporting contamination control, QC microbiology, manufacturing microbiology, inspection readiness, and technical consistency across Amgen Operations. This role partners with Quality, Manufacturing, Process Development, Regulatory Affairs-CMC, Cellular Sciences, site laboratories, and global technical networks to ensure science-based, compliant, and practical microbiology decisions. This is a full-time remote position

Requirements

• 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 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
• In addition to meeting at least one of the above requirements, you must have a minimum of 3 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Your managerial experience may run concurrently with the required technical experience referenced above

Nice To Haves

• 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.
• At least 3 years of experience leading microbiology laboratories, environmental monitoring programs, or contamination control technical workstreams.
• 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.
• 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.

Responsibilities

• 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.

Benefits

• 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, and 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree