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.