Senior QA & Customer Project Lead

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 110,000 - 150,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Quality Assurance, Customer & Project Lead to manage customer-facing quality activities across development, validation, and manufacturing within a CDMO setting. You will collaborate with Project Management, Manufacturing, Regulatory Affairs, and Quality to ensure compliance and timely delivery.

Responsibilities include customer communications, batch disposition support, CAPA management, audits, and APQR/PQR preparation, while maintaining data

Qualifications

• Education: Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, Life Sciences or related field.
• Minimum five (5) years of Quality Assurance experience in pharmaceutical, biotechnology, or regulated life sciences.
• CDMO/CMO experience preferred.
• Customer-facing Quality activities experience.
• Strong knowledge of regulatory requirements (21 CFR, EU GMP) and data integrity.

Responsibilities

• Serve as day-to-day Quality contact for assigned customers and programs.
• Coordinate QA reviews and ensure timely closure of actions.
• Perform or coordinate batch release reviews and product disposition processes.
• Lead investigations, deviations, CAPAs, and customer audits.
• Prepare APQRs/PQRs and support annual product quality reviews.
• Maintain dashboards and metrics for quality performance.

Skills

Quality Assurance

Customer Quality

Project Management

Regulatory Compliance

CAPA

Data Integrity

Education

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

Advanced degree preferred

Tools

TrackWise

MasterControl

Veeva

SAP

Job description

Piramal Pharma Solutions is seeking a Senior Quality Assurance, Customer & Project Lead to manage customer-facing quality activities across development, validation, and manufacturing within a CDMO setting. You will collaborate with Project Management, Manufacturing, Regulatory Affairs, and Quality to ensure compliance and timely delivery.

Responsibilities include customer communications, batch disposition support, CAPA management, audits, and APQR/PQR preparation, while maintaining data