Senior QC Leader, Analytical & Microbiology

Piramal Pharma Limited; Lexington (KY); On-site; USD 120,000 - 170,000; Full time

Job summary

Piramal Pharma Solutions in Lexington, KY is hiring a Sr. Manager, Quality Control to lead Analytical Quality Control and Microbiology laboratories, driving quality, efficiency, and regulatory readiness.

You will provide strategic direction, oversee testing programs, and ensure compliance with FDA/EMA guidelines while aligning with company objectives. You will manage budgets, mentor QC staff, liaise with clients and regulators, and implement quality improvement plans to sustain inspection

Qualifications

• Minimum of ten (10) years’ progressive experience in a regulated cGMP industry is required, with five (5) years’ management experience.
• Must have experience working within a GMP parenteral/sterile manufacturing environment, contract manufacturing a plus.
• Strong/demonstrated knowledge of cGMP regulations.
• Possess excellent technical writing and oral communication skills.
• Six Sigma Green Belt, Benchmarking and Project Management experience preferred.

Responsibilities

• Direct oversight of activities performed within Quality Control Laboratories.
• Monitor revenue goals ensuring that Laboratories meet or exceed expectations.
• Develop and manage department budgets.
• Regularly monitor FDA, EMA, PMDA and other agencies' requirements and guidelines for PPS laboratory operations.
• Establish short and long-range plans for timely/testing activities per business priorities and regulatory requirements.
• Oversee laboratory instrumentation, procurement, qualification, calibration and maintenance.

Education

B.A. or B.S in scientific related field

Job description

Piramal Pharma Solutions in Lexington, KY is hiring a Sr. Manager, Quality Control to lead Analytical Quality Control and Microbiology laboratories, driving quality, efficiency, and regulatory readiness.

You will provide strategic direction, oversee testing programs, and ensure compliance with FDA/EMA guidelines while aligning with company objectives. You will manage budgets, mentor QC staff, liaise with clients and regulators, and implement quality improvement plans to sustain inspection