Senior Quality Control & Compliance Leader

Piramal Pharma Ltd; Lexington (KY); On-site; USD 110,000 - 160,000; Full time

Job summary

Piramal Pharma Solutions in Lexington, KY, is seeking a Sr. Manager, Quality Control to lead the Analytical and Microbiology QC labs and drive quality, efficiency, and standardization across the department.

Reporting to the Director of Quality, you will guide testing activities, monitor regulatory requirements (FDA/ EMA/ PMDA), manage budgets, CAPAs, and inspections, and develop staff while collaborating with project managers, clients, and regulatory agencies to ensure continuous improvement and

Qualifications

• Minimum of ten (10) years’ progressive experience in a regulated cGMP industry.
• Five (5) years’ management experience.
• Experience in GMP parenteral/sterile manufacturing environment preferred.
• Strong/demonstrated knowledge of cGMP regulations.
• Possess excellent technical writing and oral communication skills.
• Six Sigma Green Belt, Benchmarking and Project Management experience preferred.
• Ability to travel as needed.

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 applicable standards and guidelines from FDA, EMA, PMDA and other authorities for incorporation into laboratory operations.
• Establish short and long-range plans for timely testing activities.
• Oversee the stability study program and regulatory compliance.
• Oversee laboratory instrumentation procurement, qualification, maintenance, and calibration.
• Develop and implement Laboratory Programs and SOPs compliant with regulatory requirements.
• Oversee all quality investigations (deviations, CAPA, LIR).
• Ensure inspection readiness and safe laboratory practices.
• Ensure staff training programs and ongoing development.
• Lead and mentor QC team; allocate resources to meet goals.

Skills

Leadership

Analytical thinking

Regulatory knowledge

Technical writing

Oral communication

Travel readiness

Education

B.A. or B.S in scientific field

Tools

LIMS

Empower

Job description

Piramal Pharma Solutions in Lexington, KY, is seeking a Sr. Manager, Quality Control to lead the Analytical and Microbiology QC labs and drive quality, efficiency, and standardization across the department.

Reporting to the Director of Quality, you will guide testing activities, monitor regulatory requirements (FDA/ EMA/ PMDA), manage budgets, CAPAs, and inspections, and develop staff while collaborating with project managers, clients, and regulatory agencies to ensure continuous improvement and