Director of Quality Control & Compliance

Piramal Pharma Solutions; Lexington (KY); On-site; USD 140,000 - 190,000; Full time

Job summary

Piramal Pharma Solutions is seeking a senior-quality leader to oversee the Quality Control Laboratories. The role reports to the Director of Quality and drives compliance, process improvement, and readiness for regulatory inspections.

Responsibilities include budget management, KPI analyses, and cross-functional collaboration with project managers, clients, and regulators to ensure quality and efficiency across laboratory operations.

Qualifications

• Experience working in a regulated cGMP environment.
• Strong technical writing and oral communication skills.
• Six Sigma Green Belt and project management exposure preferred.
• Parenteral/sterile GMP manufacturing experience is required or a plus.
• Willingness to travel as needed.

Responsibilities

• Direct oversight of Quality Control Laboratories activities.
• Monitor and help meet revenue goals for Laboratories.
• Develop and manage department budgets.
• Stay updated with FDA/EMA/PMDA guidelines and implement in QC operations.
• Ensure regulatory compliance and readiness for inspections (PIR).
• Oversee lab instrumentation procurement, qualification, maintenance and calibration.
• Develop, implement and manage Laboratory Programs, SOPs and record-keeping.

Skills

cGMP knowledge

Technical writing

Oral communication

Six Sigma Green Belt

Project management

Education

B.A. or B.S in scientific field

Job description

Piramal Pharma Solutions is seeking a senior-quality leader to oversee the Quality Control Laboratories. The role reports to the Director of Quality and drives compliance, process improvement, and readiness for regulatory inspections.

Responsibilities include budget management, KPI analyses, and cross-functional collaboration with project managers, clients, and regulators to ensure quality and efficiency across laboratory operations.