Senior Quality Control Leader, Pharma (cGMP)

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

Job summary

Piramal Pharma Solutions in Lexington, KY seeks a Sr. Manager, Quality Control to lead Analytical Quality Control and Microbiology labs, driving strategic direction, efficiency, and regulatory compliance.

You will oversee Lab operations, CAPAs, safety, and staff development while aligning with FDA and industry standards. The role requires extensive cGMP experience in parenteral/sterile manufacturing, strong technical writing and communication skills, and the ability to travel as needed.

Qualifications

• Bachelors degree in a scientific field is required or preferred.
• Experience in a regulated cGMP industry with parenteral/sterile manufacturing is essential.
• Strong knowledge of cGMP regulations and quality systems.

Responsibilities

• Direct oversight of QC Laboratories and QA systems within AQC/MQC.
• Ensure compliance with FDA/EMA/other regulatory guidelines and audits.
• Develop and manage department budgets and CAPA programs.
• Lead laboratory safety, training, and continuous improvement initiatives.
• Champion data integrity, trend analysis, and KPI monitoring.
• Mentor QC staff and coordinate with project managers and clients.

Skills

cGMP regulations

Technical writing

Oral communication

Travel as needed

Six Sigma Green Belt / Project Mgmt

Education

B.A./B.S. in scientific field

Job description

Piramal Pharma Solutions in Lexington, KY seeks a Sr. Manager, Quality Control to lead Analytical Quality Control and Microbiology labs, driving strategic direction, efficiency, and regulatory compliance.

You will oversee Lab operations, CAPAs, safety, and staff development while aligning with FDA and industry standards. The role requires extensive cGMP experience in parenteral/sterile manufacturing, strong technical writing and communication skills, and the ability to travel as needed.