Quality Compliance Associate Director – Aseptic Processing

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a subject matter expert in aseptic processing and contamination control for Quality Compliance, Manufacturing, and site teams.

• Assist in the contamination control program, which includes site engagement, network participation, metrics analysis, risk identification, and escalation of critical issues.

• Play a role in the creation, revision, and execution of global standards, procedures, technical guidance, and quality intelligence documents related to aseptic processing and contamination control.

• Aid in conducting periodic contamination control reviews, trend assessments, and state-of-control evaluations for relevant sites, processes, and products.

• Offer technical expertise for environmental monitoring, bioburden control, endotoxin testing, microbial identification, disinfectant efficacy, cleaning and disinfection, gowning, aseptic practices, utilities, facilities, and laboratory controls.

• Collaborate with site Quality, Manufacturing, Engineering, and QC laboratories to ensure consistent adherence to contamination control standards.

• Provide technical evaluations and recommendations for microbiology investigations, deviations, CAPAs, risk assessments, change controls, audit findings, and inspection commitments.

• Assist in the evaluation and implementation of new or enhanced technologies, practices, and tools for contamination control.

• Participate in Global Aseptic Council activities, technical forums, communities of practice, and discussions aimed at network alignment.

• Support regulatory inspections, internal audits, health authority commitments, and activities related to inspection readiness concerning microbiology, contamination control, QC laboratories, and manufacturing processes.

• Provide technical input for audit responses, regulatory inspection replies, CAPA plans, and effectiveness checks.

• Review regulatory filings, responses, or technical documents related to aseptic processing, as assigned.

• Stay informed on relevant regulatory, compendial, and industry developments and assist in translating them into actionable expectations for sites and functions.

• Lead or assist in cross-functional projects focused on aseptic processes, contamination control, laboratory practices, inspection readiness, or quality enhancement.

⛳️ Requirements

• Doctorate degree with 3 years of experience in Quality, Microbiology, Manufacturing, or a relevant regulated industry OR a Master’s degree with 7 years of experience OR a Bachelor’s degree with 9 years of experience OR an Associate’s degree with 12 years of experience OR a High school diploma/GED with 14 years of experience in Quality, Microbiology, Manufacturing, or a relevant regulated industry.

• At least 3 years of experience in directly managing individuals and/or leadership experience in leading teams, projects, programs, or directing resource allocation.

• Academic background in Life Science, Microbiology, Biology, Biological Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, or a related scientific field.

• Over 8 years of experience in Quality, QC microbiology, Manufacturing, contamination control, sterility assurance, or a related GMP function within the biotechnology or pharmaceutical sectors.

• A minimum of 3 years of experience in aseptic processing, leading environmental monitoring programs, or technical workstreams related to contamination control.

• Strong technical expertise in 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 in supporting GMP investigations, deviations, CAPAs, change controls, risk assessments, audits, inspection readiness, or regulatory inspection activities.

• Background in biologics, sterile manufacturing, aseptic processing, drug substance or product manufacturing, or QC microbiology laboratory operations.

• Experience in contributing to global or multi-site standards, procedures, technical guidance, training materials, quality intelligence, or quality system enhancements.

• Ability to interpret and implement GMP, GxP, regulatory, compendial, and industry standards in microbiology, manufacturing, Quality Control, and contamination control processes.

• Experience in supporting or engaging with technical networks, communities of practice, Centers of Excellence, or cross-site microbiology forums.

• Experience in evaluating or implementing new manufacturing technologies, rapid microbiological methods, automation, data trending tools, or contamination control advancements.

• Proven ability to lead cross-functional teams, influence without direct authority, communicate complex technical concepts clearly, and manage multiple priorities.

• Capability to work effectively with global and virtual teams across time zones while adapting approaches based on technical complexity, regulatory factors, and stakeholder needs.

• Proficient English written and verbal communication skills; proficiency in additional languages is advantageous.

• Willingness to travel domestically and internationally up to 20% of the time.

🏝️ Benefits

• A comprehensive employee benefits package, which includes 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 feasible.