QC Microbiological Laboratory Supervisor
Pubblicato il 31-07-2026 - Experteer Italy in Ferentino
QC Microbiological Laboratory Supervisor
As QC Microbiological Laboratory Supervisor, you will lead the microbiological QC lab to ensure compliant, on-time testing and high-quality results. You’ll provide technical leadership across operations supporting pharma manufacturing and release, while driving audits, CAPAs, and continuous improvement. You will mentor the team, optimize workflows, and partner with cross-functional groups to uphold safety and quality. This role offers impact across regulatory compliance, product quality, and customer satisfaction in a global setting.
- Lead and coordinate microbiological QC testing in compliance with safety regs, approved methods, and GMP standards
- Provide technical oversight of lab operations from raw material testing to finished product release and stability studies
- Support audits and inspections by coordinating cross-functional activities and ensuring timely documentation
- Draft and review specifications, study protocols, analytical methods, and SOPs per GMP and quality standards
- Participate in customer meetings to discuss technical topics within microbiology
- Lead investigations of OOS/OOT, and implement CAPAs
- Oversee Method Development, Validation, and Transfer activities for projects
- Collaborate on department budget and CAPEX; optimize lab operations
- Drive operational excellence through Lean and PPI, mentoring, and process improvements
- Lead, coach,
and develop the team with clear objectives and performance management
- Bachelor's degree or higher in Biology, Microbiology, Biochemistry, Pharmaceutical Chemistry and Technology (CTF), or related scientific discipline
- Several years of experience in Microbiological Quality Control in pharma/biotech
- At least 3 years in a people leadership role managing laboratory operations
- Experience in pharmaceutical manufacturing, preferably aseptic environment
- Strong knowledge of cGMP, FDA, EU GMP, ICH, and pharmaceutical quality systems
- Knowledge of Quality Risk Management, risk assessment, and Root Cause Analysis
- Understanding of ALCOA+ Data Integrity principles and xlwpduy regulatory expectations
- Excellent technical writing skills for SOPs, investigations, methods, protocols, and regulatory docs
- Strong leadership, problem-solving, and team management skills
- Excellent interpersonal and communication skills; ability to engage stakeholders across levels
- Ability to manage conflicting priorities in a dynamic team
- Proficiency with Microsoft Office, LIMS, and eQMS
- Professional certifications in Quality Systems, Regulatory Compliance, Lean Six Sigma, or Project Management are advantageous
As QC Microbiological Laboratory Supervisor, you will lead the microbiological QC lab to ensure compliant, on-time testing and high-quality …
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