Senior Manager, QC Microbiology

Key Accountabilities/Core Job Responsibilities

• Lead, mentor, and develop a 3–5 person QC Microbiology team; foster a strong safety, GMP (ALCOA+) and continuous-improvement culture.
• Plan capacity and schedules (incl. weekends/off-shift); ensure resources, instrumentation readiness, and cross-training/coverage.
• Own the site’s risk-based Environmental Monitoring (EM) program for ISO 5/7/8 (Grade A–D) areas, including sampling plans, alert/action limits, and contamination control strategy.
• Oversee viable/non-viable, surface, air, and personnel monitoring; review/approve data and deliver routine trend reports.
• Lead EM excursions and other investigations (OOS/OOT/deviations); perform root-cause and risk/impact assessments; drive CAPAs and effectiveness checks to closure.
• Oversee and as needed, perform compendial testing (bioburden, endotoxin/LAL, sterility, microbial ID/confirmation, growth promotion) and utilities monitoring (water/gases).
• Author/review SOPs, protocols, and reports; lead method suitability/verification/transfer and manage change controls.
• Partner with Manufacturing/MSAT/QA/Engineering on aseptic practices, cleaning/disinfection programs, and overall contamination control.
• Ensure data integrity and inspection readiness; utilize LIMS/ELN and EM systems, perform periodic reviews/audit-trail oversight; host regulatory and internal audits.
• Maintain compliance with 21 CFR 211, EU GMP Annex 1, and applicable USP/EP/USP chapters; own microbiology/EM metrics, control charts, and dashboards (e.g., TAT, excursion rates, trends).

Qualifications/Skills

• Bachelor's degree required; BS in Microbiology (or related)
• Typically 8+ years of industry experience and 3+ years of management experience
• Hands-on competency across EM and core microbiology assays with ~50% lab/cleanroom presence
• Proven ownership of site EM programs and compendial testing
• Strong GMP documentation/technical writing, LIMS fluency, and basic statistical trending
• Demonstrated ability to coordinate schedules/workflows, mentor/train others, and support weekend/off-shift coverage
• Excellent communication, collaboration, and problem-solving skills
• Preferred Experience: Includes Fill-finish or cell-culture/DS and contamination-control strategy
• JMP (or equivalent) for SPC/control-charting and dashboards
• Rapid microbiological methods, disinfectant-efficacy studies, utilities monitoring (WFI/PW/clean steam/compressed gases)
• Hosting inspections/overseeing CMOs or contract labs, and validating/transferring alternative methods (USP //)
• Onsite GMP cleanroom role with routine gowning (Grade B/A as qualified), PPE and aseptic technique
• Able to stand for extended periods and lift ~25 lbs; weekend/occasional off-shift work to meet EM and production schedules