Senior Quality Control Leader - Analytical Labs

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 120,000 - 180,000; Full time

Job summary

Piramal Pharma Solutions Inc. is seeking a Sr. Manager of Quality Control in Lexington to lead Analytical and Microbiology QC operations.

You will provide strategic direction to improve quality, efficiency, and standardization across the QC department, ensuring regulatory readiness and compliance with FDA and global guidelines. Reporting to the Director of Quality, you will manage budgets, oversee validation and testing programs, and mentor QC staff while driving continuous improvement and risk

Qualifications

• Minimum 10 years in a regulated cGMP environment with 5+ years in management.
• Experience in GMP parenteral/sterile manufacturing preferred.
• Strong knowledge of cGMP regulations and quality systems.

Responsibilities

• Direct oversight of Quality Control Laboratories and testing activities.
• Monitor budgets and department performance against revenue goals.
• Ensure regulatory readiness and inspection readiness across QC operations.
• Lead CAPA, deviations, and investigations with effective problem solving.
• Develop and maintain SOPs, policies, and good record-keeping practices.

Skills

cGMP knowledge

Regulatory compliance

Quality leadership

Technical writing

Education

Bachelor's degree in Life Sciences

Tools

LIMS

Empower

QA software

Job description

Piramal Pharma Solutions Inc. is seeking a Sr. Manager of Quality Control in Lexington to lead Analytical and Microbiology QC operations.

You will provide strategic direction to improve quality, efficiency, and standardization across the QC department, ensuring regulatory readiness and compliance with FDA and global guidelines. Reporting to the Director of Quality, you will manage budgets, oversee validation and testing programs, and mentor QC staff while driving continuous improvement and risk