Senior Customer Quality & Project Assurance Lead

Piramal Pharma Solutions

Sellersville (Bucks County)

On-site

USD 120,000 - 180,000

Full time

14 days+

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Job summary

Piramal Pharma Solutions is seeking a Senior QA Manager, Customer Quality & Project Assurance to lead customer-facing Quality activities and ensure on-time delivery of Quality deliverables across development, validation, and manufacturing. You will partner with Project Management and cross-functional teams to meet commitments while ensuring cGMP compliance.

The role oversees batch disposition, investigations, complaints, CAPAs, APQRs/PQRs, and customer audits, driving continuous improvement and

Qualifications

Bachelor's degree in a relevant science field required; advanced degree preferred.
8+ years QA in pharma/regulated life sciences, with cGMP manufacturing experience.
3+ years of direct people leadership experience in a QA environment.
CDMO/CMO experience supporting multiple customers and products preferred.
Strong working knowledge of regulatory requirements (FDA/EMA/ICH) and data integrity.

Responsibilities

Lead customer quality leadership and routine quality reviews with assigned customers.
Partner with Project Management to define, prioritize, and track quality activities.
Coordinate timely QA review of batch records, test results, deviations, investigations, and disposition.
Oversee deviations, investigations, OOS/OOT events, complaints, CAPAs, and APQRs/PQRs.
Lead customer audits, maintenance of commitments, and CAPA closure with cross-functional support.
Maintain dashboards for release cycles, events, CAPA, audits, and customer commitments.