Strategic Quality & Customer Delivery Lead

Piramal Pharma Limited; Northern (KY); On-site; USD 110,000 - 150,000; Full time

Job summary

Piramal Pharma Limited is seeking a Senior Quality Assurance, Customer & Project Lead to drive customer-facing QA activities across development, validation, and manufacturing in a CDMO setting. You will manage batch release reviews, investigations, CAPAs, and quality agreements while collaborating with cross-functional teams to meet commitments and maintain cGMP compliance.

You will coordinate quality events, regulatory support, and APQRs/PQRs, contributing to continuous improvement and robust

Qualifications

• 5+ years of QA experience in pharmaceutical/regulated life sciences.
• CDMO/CMO environment experience preferred.
• Knowledge of 21 CFR Parts 210-211, EU GMP, ICH guidance.
• Experience with customer-facing QA activities and cross-functional collaboration.

Responsibilities

• Serve as the day-to-day QA contact for assigned customers and programs.
• Plan, track, and drive quality activities aligned with project plans and milestones.
• Review batch records, deviations, investigations, and disposition documentation.
• Coordinate deviations, investigations, CAPAs, complaints, audits, and quality events.
• Prepare APQRs/PQRs and maintain quality agreements and customer commitments.
• Maintain dashboards and metrics for release cycle time, investigations, and CAPA effectiveness.
• Support regulatory inspections and customer audits with records and responses.
• Ensure data integrity and compliant, traceable documentation.

Skills

Quality assurance

Customer quality

Project management

Regulatory knowledge

Quality systems

Education

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

Advanced degree preferred

Tools

TrackWise

MasterControl

Veeva

SAP

Job description

Piramal Pharma Limited is seeking a Senior Quality Assurance, Customer & Project Lead to drive customer-facing QA activities across development, validation, and manufacturing in a CDMO setting. You will manage batch release reviews, investigations, CAPAs, and quality agreements while collaborating with cross-functional teams to meet commitments and maintain cGMP compliance.

You will coordinate quality events, regulatory support, and APQRs/PQRs, contributing to continuous improvement and robust