Associate Director, Quality Compliance – Microbiology

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

📋 Description

• Act as a subject matter expert in microbiology and contamination control for Quality Compliance, QC laboratories, manufacturing, and site teams.

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

• Contribute to the creation, revision, and implementation of global microbiology and contamination control standards, procedures, technical guidance, and quality intelligence documents.

• Support regular contamination control reviews, trend analyses, and state-of-control assessments for applicable sites, processes, and products.

• Offer technical insights for environmental monitoring, bioburden control, endotoxin management, 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 application of 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 assessment and implementation of new or enhanced microbiology methods, technologies, laboratory practices, and contamination control tools.

• Engage in activities of the Microbiology Center of Excellence, technical forums, communities of practice, and network alignment discussions.

• Aid in regulatory inspections, internal audits, health authority commitments, and inspection readiness activities relevant to microbiology, contamination control, QC laboratories, and manufacturing processes.

• Deliver technical input for audit responses, regulatory inspection responses, CAPA plans, and effectiveness evaluations.

• Review regulatory submissions, responses, or technical documents pertaining to microbiology-related content, as assigned.

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

• Lead or assist cross-functional initiatives related to microbiology, 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 Master’s degree with 7 years of experience in the same fields OR Bachelor’s degree with 9 years of experience OR Associate’s degree with 12 years of experience OR High school diploma/GED with 14 years of experience in Quality, Microbiology, Manufacturing, or a relevant regulated industry.

• At least 3 years of experience directly managing personnel and/or demonstrating leadership in guiding teams, projects, programs, or resource allocation.

• Preferred Qualifications: Background in Life Science, Microbiology, Biology, Biological Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, or related scientific disciplines.

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

• Profound technical understanding of microbiology and contamination control practices, encompassing 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.

• 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.

• Capability to interpret and apply GMP, GxP, regulatory, compendial, and industry standards to microbiology, manufacturing, Quality Control, and contamination control processes.

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

• Familiarity with evaluating or implementing new microbiology technologies, rapid microbiological methods, laboratory automation, data trending tools, or contamination control advancements.

• Ability to work efficiently with global and virtual teams across different time zones while adjusting approaches based on technical complexity, regulatory factors, and stakeholder requirements.

🏝️ 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.

• Flexible spending accounts.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where possible.