Role Overview
A leading life sciences organization is seeking an experienced Microbiology QC Lead/Manager to play a pivotal role during a major facility expansion. This position focuses on building the foundational operational readiness-establishing high-performing teams, robust systems, and technical capabilities-to support long-term manufacturing growth. In addition to expansion-driven projects, the successful candidate will provide functional leadership, drive continuous improvement, and oversee routine laboratory operations.
Core Responsibilities
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Site Expansion & Project Leadership: Oversee QC Micro readiness for facility expansion; define, procure, and qualify laboratory instrumentation, media, and testing workflows.
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Team Leadership & Development: Supervise, mentor, and coach laboratory staff; direct training programs to ensure personnel are qualified for upcoming operational milestones.
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GMP Documentation & Quality Systems: Author, review, and approve critical quality documentation (SOPs, protocols, risk assessments, and validation reports); manage deviations, CAPAs, and change controls.
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Contamination Control & Testing Programs: Direct environmental monitoring (EM) strategies, utility testing, and contamination control initiatives aligned with current regulatory and aseptic processing expectations.
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Cross-Functional Collaboration: Serve as the primary QC Micro Subject Matter Expert (SME) across project teams, partnering closely with Quality Assurance, Manufacturing, and Engineering.
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Inspection Readiness & Data Integrity: Maintain strict compliance with cGMP, ALCOA+ principles, and Right-First-Time (RFT) standards; represent the department during internal and regulatory audits.
Candidate Profile & Qualifications
Required Qualifications & Experience:
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Education: Bachelor's Degree in Microbiology, Biology, or a relevant Scientific discipline.
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Experience: 6+ years of progressive Quality Control / GMP laboratory experience within the biopharmaceutical, pharmaceutical, or medical device sectors.
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Demonstrated supervisory or team leadership experience within a regulated manufacturing context.
Key Technical Competencies:
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Core Microbiology Expertise: Deep working knowledge of environmental monitoring, aseptic processing controls, and microbiological testing methodologies.
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Capital & Readiness Projects: Experience in laboratory setup, equipment commissioning/qualification, or technology transfers is highly advantageous.
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Quality & Compliance: Comprehensive understanding of cGMP regulations, regulatory agency expectations (HPRA/FDA), and investigation frameworks (Root Cause Analysis).
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Leadership & Communication: Excellent stakeholder management, technical writing, and problem-solving skills, with a track record of driving operational excellence.
