Senior Microbiology QC & Lab Leadership

Job Responsibilities:

• Oversee Quality Control laboratories, including Microbiology and Environmental Monitoring.
• Ensure all required testing is performed accurately and on time.
• Approve specifications, sampling instructions, test methods, procedures, and other QC-related protocols.
• Manage and monitor contract testing laboratories for compliance and test results.
• Ensure proper validation and qualification processes are completed and approved.
• Review and approve laboratory records before submission to the QA department.
• Coach and develop team members to foster ownership and responsibility within the group.
• Ensure team compliance with company policies, procedures, and regulations.
• Set clear goals aligned with site strategies and manage team performance effectively.
• Demonstrate accountability in leading change, completing projects, and driving continuous improvement.
• Provide leadership in employee relations through clear communication, coaching, and development to remove obstacles for team progress.
• Enforce strict safety compliance and ensure safety meetings are regularly held.
• Lead the team in continuous improvement initiatives.
• Maintain cleanliness and proper maintenance of department facilities and equipment.
• Track and communicate team progress against individual, team, and site Key Performance Indicators (KPIs).
• Lead or support investigations, reviewing and approving area quality and safety reports, and ensuring timely completion of corrective actions.
• Review and update controlled documents related to the area of responsibility.
• Identify opportunities for risk reduction, cost savings, and service improvements.

Qualifications:

• Bachelor's Degree in a scientific discipline or equivalent work experience.
• 12+ years of relevant leadership experience in Quality Control, including 2+ years in management, preferably with teams of 10+ multi-shift employees.
• Strong knowledge of aseptic cGMP requirements and laboratory equipment/product validation.
• Hands-on experience in a pharmaceutical manufacturing facility, with a deep understanding of QC laboratory testing, analytical methods, and statistical quality control.
• Expertise in the manufacturing and control of finished products.
• Familiarity with FDA, EU, ISO, USP, and other regulatory testing guidelines, including analytical method validation.
• Comprehensive understanding of quality systems.