Senior QA & Customer Quality Lead (CDMO)

Piramal Pharma Solutions; Sellersville (Bucks County); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

Piramal Pharma Solutions in the United States seeks a Senior Quality Assurance, Customer & Project Lead to drive customer-facing quality activities across development, validation, and commercial manufacturing. You will coordinate QA reviews, CAPAs, audits, and APQRs while maintaining cGMP compliance.

The role requires extensive collaboration with Project Management, Manufacturing, Regulatory, and Technical Services to ensure timely commitments and high-quality outcomes in a CDMO environment.

Qualifications

• Education and governance in cGMP pharmaceutical quality expected.
• Experience supporting customer-facing Quality activities and cross-functional teams.
• Strong knowledge of QA systems and regulatory requirements.

Responsabilités

• Serve as day-to-day Quality contact for customers and programs.
• Plan, track, and execute Quality activities aligned with project plans.
• Review batch records and support disposition decisions with independent Authority.
• Coordinate investigations, deviations, and CAPA lifecycle.
• Draft responses to customer queries and audits, ensuring timely closure.
• Prepare APQRs/PQRs and support regulatory inspections.
• Maintain dashboards tracking release cycle time and commitments.

Connaissances

Customer-facing QA

Project quality

Batch disposition

CAPA management

Audit coordination

Quality metrics

Regulatory compliance

Data integrity

Root cause analysis

Risk assessment

Formation

Bachelor’s degree in Chemistry or related

Outils

TrackWise

MasterControl

Veeva

SAP

Description du poste

Piramal Pharma Solutions in the United States seeks a Senior Quality Assurance, Customer & Project Lead to drive customer-facing quality activities across development, validation, and commercial manufacturing. You will coordinate QA reviews, CAPAs, audits, and APQRs while maintaining cGMP compliance.

The role requires extensive collaboration with Project Management, Manufacturing, Regulatory, and Technical Services to ensure timely commitments and high-quality outcomes in a CDMO environment.