Stability Program Lead — QC, Compliance & Data

Ppl Healthcare; Sellersville (Bucks County); Presencial; USD 100.000 - 140.000; Jornada completa

Descripción de la vacante

Piramal Pharma Solutions is seeking a Stability Program Supervisor to lead the site Stability Program in compliance with cGMP and regulatory requirements. The role involves coordinating sample management, testing, data review, and reporting to ensure timely study closure.

The candidate will maintain schedules, oversee stability chamber operations, and drive quality improvements through root-cause investigations and CAPAs, while partnering with QC, Regulatory Affairs, and Manufacturing teams.

Formación

• Minimum 5 years of pharmaceutical/CDMO QC experience, with stability-program exposure.
• Strong understanding of cGMP, FDA, USP, ICH stability guidance.
• Experience coordinating stability studies, data review and reporting.

Responsabilidades

• Lead day-to-day stability program execution per procedures and regulatory requirements.
• Maintain Master Stability Schedule: initiations, pulls, testing, review, reporting, closure.
• Oversee sample receipt, labeling, storage, inventory, and disposition with traceability.
• Monitor test status, capacity, and regulatory deadlines; escalate risks.
• Ensure investigations, CAPAs, and deviations are properly documented and closed.

Conocimientos

Stability program coordination

Regulatory compliance

Cross-functional collaboration

Technical writing

Educación

Bachelor's degree in Chemistry or related field

Herramientas

LIMS

eQMS

Descripción del empleo

Piramal Pharma Solutions is seeking a Stability Program Supervisor to lead the site Stability Program in compliance with cGMP and regulatory requirements. The role involves coordinating sample management, testing, data review, and reporting to ensure timely study closure.

The candidate will maintain schedules, oversee stability chamber operations, and drive quality improvements through root-cause investigations and CAPAs, while partnering with QC, Regulatory Affairs, and Manufacturing teams.