Senior Quality Assurance & Client Projects Lead

Piramal Pharma Limited; Sellersville (Bucks County); Sur place; USD 90 000 - 140 000; Plein temps

Résumé du poste

Piramal Pharma Solutions, a CDMO leader, seeks a Senior Quality Assurance, Customer & Project Lead to drive customer-facing QA activities across development, validation, and manufacturing. You will manage quality deliverables, CAPAs, audits, and regulatory support with cross-functional teams to ensure cGMP compliance.

Ideal candidates have 5+ years of QA in life sciences, CDMO/CMO experience, and strong knowledge of 21 CFR Parts 210/211, EU GMP, and data integrity standards.

Qualifications

• Minimum five years of Quality Assurance experience in pharmaceutical, biotechnology, or regulated life sciences.
• Experience supporting customer-facing Quality activities and partnering with cross-functional teams to meet milestones.
• CDMO/CMO experience strongly preferred.
• Working knowledge of 21 CFR Parts 210 and 211, EU GMP, ICH guidance, data integrity expectations.
• Experience with batch disposition, deviations, investigations, CAPAs, audits, and Quality Agreements.

Responsabilités

• Serve as the day-to-day Quality contact for assigned customers and programs; coordinate responses and quality reviews.
• Plan, track, and complete QA activities aligned with project plans, milestones, and schedules.
• Review and approve batch records, deviations, investigations, certificates, and supporting documentation for disposition.
• Review deviations, investigations, OOS/OOT, complaints, CAPAs, and documentation for timely closure.
• Draft or coordinate responses for customer audits; track commitments and CAPAs to closure.
• Develop, review, and track APQRs/PQRs; identify trends and required actions.
• Support Quality Agreements and customer notifications; ensure compliance and timely completion.

Connaissances

Customer quality

Project quality

Quality assurance

Quality systems

Documentation

Formation

Bachelor's degree in Chemistry/Biology/QA related

Advanced degree preferred

Outils

TrackWise

MasterControl

Veeva

SAP

Description du poste

Piramal Pharma Solutions, a CDMO leader, seeks a Senior Quality Assurance, Customer & Project Lead to drive customer-facing QA activities across development, validation, and manufacturing. You will manage quality deliverables, CAPAs, audits, and regulatory support with cross-functional teams to ensure cGMP compliance.

Ideal candidates have 5+ years of QA in life sciences, CDMO/CMO experience, and strong knowledge of 21 CFR Parts 210/211, EU GMP, and data integrity standards.