Senior QA Lead, Customer & Project Quality

Piramal Pharma Solutions; Sellersville (Bucks County); On-site; USD 120,000 - 150,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Quality Assurance, Customer & Project Lead to drive customer-facing quality activities across development, validation, and manufacturing within a CDMO. You will manage batch release, investigations, CAPAs, and audits, partnering with cross-functional teams to meet customer commitments while upholding cGMP standards.

The role requires strong regulatory knowledge, data integrity, and ability to deliver timely quality decisions in a fast-paced

Qualifications

• Minimum five (5) years of Quality Assurance experience in pharmaceutical/regulated life sciences.
• Experience supporting customer-facing Quality activities and cross-functional teams.

Responsibilities

• Serve as day-to-day Quality contact for assigned customers and programs.
• Coordinate QA reviews, deviations, investigations, and CAPAs to closure.
• Prepare updates, track open actions, and escalate matters requiring management attention.
• Coordinate audit planning, readiness, and response drafting.
• Prepare APQRs/PQRs and annual product quality reviews.

Skills

Customer Quality

Project Quality

Quality Assurance

Cross-functional

Regulatory Knowledge

Education

Bachelor’s degree

Tools

TrackWise

MasterControl

Veeva

SAP

Job description

Piramal Pharma Solutions is seeking a Senior Quality Assurance, Customer & Project Lead to drive customer-facing quality activities across development, validation, and manufacturing within a CDMO. You will manage batch release, investigations, CAPAs, and audits, partnering with cross-functional teams to meet customer commitments while upholding cGMP standards.

The role requires strong regulatory knowledge, data integrity, and ability to deliver timely quality decisions in a fast-paced