Senior QA Leader, Customer Quality & Project Assurance

Piramal Pharma Limited; Sellersville (Bucks County); Sur place; USD 140 000 - 190 000; Plein temps

Résumé du poste

Piramal Pharma Solutions is seeking a Senior QA Manager, Customer Quality & Project Assurance to lead customer-facing quality activities and ensure timely delivery of quality commitments across development, validation, and commercial manufacturing in a CDMO setting.

You will partner with Project Management, Manufacturing, Regulatory Affairs, and QA IT to manage batch disposition, investigations, CAPAs, audits, and APQRs, while building trusted relationships with key customers.

Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, Life Sciences, or related discipline is required; an advanced degree is preferred.
• Minimum eight (8) years of Quality Assurance experience in pharmaceutical, biotechnology, or regulated life sciences, including CDMO/CMO environments.
• Minimum three (3) years of direct people-leadership experience, including workload planning and performance management.
• CDMO/CMO experience supporting multiple customers and products is strongly preferred.
• Experience managing customer-facing Quality activities and partnering with Project Management to meet milestones.
• Experience in Quality Operations: batch disposition, deviations, investigations, CAPAs, APQRs/PQRs, change controls, and quality agreements.
• Regulatory knowledge of 21 CFR Parts 210/211, EU GMP, ICH guidance, data integrity expectations.
• Experience with electronic Quality systems such as TrackWise, MasterControl, Veeva, SAP or comparable platforms.

Responsabilités

• Lead customer quality leadership, build trusted relationships, and oversee routine Quality reviews and escalations.
• Partner with Project Management to define and deliver Quality activities aligned with project plans and milestones.
• Coordinate QA review of batch records, test results, deviations, investigations and disposition while maintaining independent Quality authority.
• Oversee deviations, nonconformances, investigations, OOS/OOT events, complaints, CAPAs, and risk assessments.
• Lead customer audits, respond with commitments, track CAPA closure and verify effectiveness.
• Oversee APQRs/PQRs and Annual Product Quality Reviews with evaluations of trends.
• Maintain dashboards for release cycle time, events, audits, and customer commitments; escalate risks with recovery plans.

Description du poste

Piramal Pharma Solutions is seeking a Senior QA Manager, Customer Quality & Project Assurance to lead customer-facing quality activities and ensure timely delivery of quality commitments across development, validation, and commercial manufacturing in a CDMO setting.

You will partner with Project Management, Manufacturing, Regulatory Affairs, and QA IT to manage batch disposition, investigations, CAPAs, audits, and APQRs, while building trusted relationships with key customers.