Senior QA Manager, Customer Quality & Projects

Piramal Pharma Ltd; Sellersville (Bucks County); On-site; USD 120,000 - 180,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior QA Manager, Customer Quality & Project Assurance to lead customer-facing Quality activities across development, validation, and manufacturing within a CDMO environment.

You will partner with Project Management and cross-functional teams to ensure on-time delivery of quality commitments, manage audits, investigations, CAPAs, and APQRs, and drive continuous improvement in customer satisfaction and product quality.

Qualifications

• Bachelor’s degree in a scientific discipline is required; advanced degree preferred.
• Minimum eight (8) years of QA experience in pharmaceutical, biotechnology, or regulated life sciences.
• Minimum three (3) years of direct people-leadership experience.
• CDMO/CMO experience is strongly preferred.
• Demonstrated experience managing customer-facing Quality activities and partnering with cross-functional teams.
• Experience with batch disposition, deviations, investigations, CAPAs, APQRs/PQRs, audits, and Quality Agreements.
• Strong working knowledge of 21 CFR Parts 210 and 211, EU GMP, ICH guidance, data integrity, and risk-based decision-making.
• Experience with electronic Quality systems such as TrackWise, MasterControl, Veeva, SAP, or comparable platforms is preferred.

Responsibilities

• Lead customer quality leadership and build trusted relationships with assigned customers.
• Define, prioritize, and track Quality activities aligned with project plans and milestones.
• Coordinate timely QA review of batch records and disposition documentation.
• Oversee deviations, investigations, and CAPA closure with risk-based analyses.
• Lead customer audits and ensure timely responses and CAPA closures.
• Develop dashboards to monitor release cycles, events, and commitments.
• Lead and develop approximately 4–6 Quality professionals.

Education

Bachelor’s degree in a scientific discipline

8+ years of QA experience in pharma/regulated life sciences

3+ years of people leadership experience

CDMO/CMO experience

Customer-facing Quality leadership

Project quality management

Quality mindset and process improvement

Tools

TrackWise

MasterControl

Veeva

SAP

Job description

Piramal Pharma Solutions is seeking a Senior QA Manager, Customer Quality & Project Assurance to lead customer-facing Quality activities across development, validation, and manufacturing within a CDMO environment.

You will partner with Project Management and cross-functional teams to ensure on-time delivery of quality commitments, manage audits, investigations, CAPAs, and APQRs, and drive continuous improvement in customer satisfaction and product quality.