QC Micro Manager

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

• Site Expansion & Project Leadership: Oversee QC Micro readiness for facility expansion; define, procure, and qualify laboratory instrumentation, media, and testing workflows.

• Team Leadership & Development: Supervise, mentor, and coach laboratory staff; direct training programs to ensure personnel are qualified for upcoming operational milestones.

• GMP Documentation & Quality Systems: Author, review, and approve critical quality documentation (SOPs, protocols, risk assessments, and validation reports); manage deviations, CAPAs, and change controls.

• Contamination Control & Testing Programs: Direct environmental monitoring (EM) strategies, utility testing, and contamination control initiatives aligned with current regulatory and aseptic processing expectations.

• Cross-Functional Collaboration: Serve as the primary QC Micro Subject Matter Expert (SME) across project teams, partnering closely with Quality Assurance, Manufacturing, and Engineering.

• 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:

• Education: Bachelor's Degree in Microbiology, Biology, or a relevant Scientific discipline.

• Experience: 6+ years of progressive Quality Control / GMP laboratory experience within the biopharmaceutical, pharmaceutical, or medical device sectors.

• Demonstrated supervisory or team leadership experience within a regulated manufacturing context.

Key Technical Competencies:

• Core Microbiology Expertise: Deep working knowledge of environmental monitoring, aseptic processing controls, and microbiological testing methodologies.

• Capital & Readiness Projects: Experience in laboratory setup, equipment commissioning/qualification, or technology transfers is highly advantageous.

• Quality & Compliance: Comprehensive understanding of cGMP regulations, regulatory agency expectations (HPRA/FDA), and investigation frameworks (Root Cause Analysis).

• Leadership & Communication: Excellent stakeholder management, technical writing, and problem-solving skills, with a track record of driving operational excellence.