Senior QA Lead: Customer & Project Delivery

Piramal Pharma Limited; Northern (KY); On-site; USD 90,000 - 130,000; Full time

Job summary

Piramal Pharma Limited is seeking a Senior Quality Assurance Specialist to lead customer-facing quality activities across development, validation, commercial manufacturing, and lifecycle programs in a CDMO environment. You will ensure cGMP compliance and manage QA reviews, investigations, CAPAs, and customer audits with cross-functional teams.

The role emphasizes independent quality judgment, data integrity, and timely communication with customers, management, and stakeholders.

Qualifications

• Bachelor’s degree in a scientific discipline is required, advanced degree preferred.
• Minimum five years of QA experience in pharma/biotech or regulated life sciences.
• Experience with CDMO/CMO environments and customer-facing QA activities.

Responsibilities

• Serve as day-to-day Quality contact for assigned customers and programs.
• Coordinate QA reviews, decisions, and action tracking to ensure timely dispositions.
• Review and coordinate batch records, deviations, investigations, and product disposition.
• Coordinate investigations, deviations, OOS/OOT events, and risk-based assessments.
• Lead CAPA development, tracking, and effectiveness verification.
• Support customer audits, regulatory inspections, and quality agreements.

Skills

Quality Assurance

Regulatory knowledge

Documentation & data integrity

Audits & inspections

CAPA management

Cross-functional collaboration

Project management

Quality metrics dashboards

Education

Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, Life Sciences

Advanced degree preferred

Tools

TrackWise

MasterControl

Veeva

SAP

Job description

Piramal Pharma Limited is seeking a Senior Quality Assurance Specialist to lead customer-facing quality activities across development, validation, commercial manufacturing, and lifecycle programs in a CDMO environment. You will ensure cGMP compliance and manage QA reviews, investigations, CAPAs, and customer audits with cross-functional teams.

The role emphasizes independent quality judgment, data integrity, and timely communication with customers, management, and stakeholders.