Senior QA & Customer Projects Leader

Piramal Critical Care, Inc.; United States; Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Piramal Pharma Solutions in the United States seeks a Sr. Quality Assurance, Customer & Project Lead to drive customer-facing QA activities across development, validation, and commercial manufacturing in a CDMO setting.

The role collaborates with Project Management, Manufacturing, Regulatory Affairs, and Quality teams to ensure cGMP compliance, timely investigations, and robust quality documentation.

Formación

• Bachelor’s degree in a scientific discipline is required; advanced degree preferred.
• Minimum five years of QA experience in pharma/regulated life sciences (CDMO/CMO preferred).
• Experience with customer-facing QA activities and cross-functional programs.

Responsabilidades

• Serve as main QA contact for assigned customers and programs; prepare updates and coordinate responses.
• Plan, track, and close quality activities aligned with project milestones and schedules.
• Review batch records, deviations, investigations, and CAPAs; ensure timely clearance and regulatory readiness.
• Coordinate audits, responses, and commitments; maintain inspection-ready documentation.
• Prepare APQRs/PQRs and perform annual product quality review data analysis.
• Maintain dashboards and trackers for release cycles, events, CAPAs, and customer commitments.

Conocimientos

Quality leadership

Customer communication

Risk assessment

Cross-functional work

Regulatory knowledge

GxP compliance

Educación

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

Herramientas

TrackWise

MasterControl

Veeva

SAP

Descripción del empleo

Piramal Pharma Solutions in the United States seeks a Sr. Quality Assurance, Customer & Project Lead to drive customer-facing QA activities across development, validation, and commercial manufacturing in a CDMO setting.

The role collaborates with Project Management, Manufacturing, Regulatory Affairs, and Quality teams to ensure cGMP compliance, timely investigations, and robust quality documentation.