Senior QA Leader, Customer Quality & Project Assurance

Piramal Pharma Limited

Northern (KY)

Hybrid

USD 110,000 - 170,000

Full time

4 days ago

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Job summary

Piramal Pharma Solutions is seeking a Senior QA Manager to lead customer-facing quality activities and ensure on-time execution of QA deliverables across development, validation, and commercial manufacturing within a CDMO framework.

The role partners with Project Management and cross-functional teams to drive batch disposition, investigations, CAPAs, and customer audits while maintaining cGMP compliance. Strong regulatory knowledge and leadership are essential.

Qualifications

Eight years of QA experience in pharmaceutical/regulated life sciences.
Three years of direct people leadership experience.
CDMO/CMO experience preferred.
Customer-facing quality management exposure.
Experience with batch disposition, deviations, investigations, CAPAs.
Knowledge of 21 CFR Parts 210 & 211, EU GMP, ICH guidelines.
Familiarity with TrackWise, MasterControl, Veeva, SAP.

Responsibilities

Oversee customer-facing QA activities and ensure on-time delivery of quality deliverables across development, validation, and manufacturing.
Lead audits, investigations, CAPAs, and customer communications.
Coordinate cross-functional teams with Project Management to meet milestones and customer commitments.
Maintain dashboards for release, CAPA, audits, and quality metrics.
Support continuous improvement and risk-based decision making.