Senior QA & Customer Program Lead

Piramal Pharma Ltd; Sellersville (Bucks County); On-site; USD 110,000 - 170,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Quality Assurance, Customer & Project Lead to drive customer-facing quality activities across development, validation, and commercial manufacturing in a CDMO setting. You will partner with Project Management, Manufacturing, Regulatory, and Quality teams to meet commitments while ensuring cGMP compliance.

The role emphasizes independent quality judgment, risk-based decision making, and timely escalation of release risks, with responsibility for audits,

Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmacy or related field.
• Minimum five years QA in pharma/regulated environment is required.
• CDMO/CMO experience strongly preferred for multi-customer work.
• Hands-on batch disposition, deviations, CAPAs, and audits experience.
• Strong regulatory knowledge and data integrity familiarity.
• Experience with electronic quality systems (TrackWise/MasterControl/Veeva).

Responsibilities

• Serve as day-to-day customer quality contact and coordinate responses.
• Plan and execute quality activities aligned with project milestones.
• Review batch records, deviations, investigations, and disposition.
• Coordinate investigations, investigations, CAPA creation and tracking.
• Draft responses to customer complaints and audits.
• Prepare APQRs/PQRs and maintain quality documentation.
• Support regulatory inspections and audits readiness.
• Maintain dashboards and track commitments across programs.
• Collaborate cross-functionally to ensure quality on time.

Skills

Ownership & prioritization

Quality judgment

Communication & stakeholder mgmt

Investigation & root-cause

Dashboards & reporting

Documentation accuracy

Cross-functional collaboration

Process improvement

Education

Bachelor’s degree in Chemistry or Life Sciences

5+ years QA in pharma/regulated environment

CDMO/CMO exposure

Experience with batch disposition & CAPAs

Regulatory knowledge (21 CFR/EU GMP)

Quality systems experience (TrackWise/MasterControl/Veeva/SAP)

Tools

TrackWise

MasterControl

Veeva

SAP

Job description

Piramal Pharma Solutions is seeking a Senior Quality Assurance, Customer & Project Lead to drive customer-facing quality activities across development, validation, and commercial manufacturing in a CDMO setting. You will partner with Project Management, Manufacturing, Regulatory, and Quality teams to meet commitments while ensuring cGMP compliance.

The role emphasizes independent quality judgment, risk-based decision making, and timely escalation of release risks, with responsibility for audits,