Senior Stability Program Lead

PPL Healthcare LLC; Sellersville (Bucks County); Presencial; USD 90.000 - 140.000; Jornada completa

Descripción de la vacante

Piramal Pharma Solutions (PPL) is seeking a Stability Program Supervisor to lead compliant, timely execution of the site Stability Program. You will supervise Stability personnel, coordinate cross-functional work, and ensure regulatory and customer commitments are met.

Responsibilities include planning, data review, trend analysis, and ensuring inspection readiness while maintaining traceability and adherence to cGMP and QA expectations.

Formación

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline; advanced degree or relevant certification preferred.
• Minimum 5 years of pharmaceutical, biotechnology, or CDMO Quality Control experience, including direct stability-program experience in a cGMP laboratory.
• Experience coordinating stability studies, sample pulls, testing, data review, trending, reports, investigations, and study closure.
• Prior supervisory, team-lead, or program-lead experience strongly preferred.
• Working knowledge of cGMP, applicable FDA regulations, USP requirements, ICH stability guidance, data integrity, and laboratory quality systems.
• Strong planning, technical writing, investigation, problem-solving, leadership, communication, and cross-functional collaboration skills.
• Proficiency with LIMS, stability management systems, eQMS, Microsoft Office, and applicable laboratory systems.

Responsabilidades

• Own day-to-day execution of the site Stability Program in accordance with approved procedures, protocols, specifications, quality agreements, and applicable regulatory requirements.
• Maintain the Master Stability Schedule for study initiation, sample placement, pull dates, testing, review, reporting, and closure.
• Oversee sample receipt, reconciliation, labeling, storage, inventory, retrieval, transfer, and disposition with complete traceability.
• Ensure stability pulls and testing are initiated and completed within required timelines and aligned with approved conditions, packaging configurations, test requirements, frequencies, and durations.
• Coordinate commercial, registration, validation, commitment, annual, investigational, and customer-specific studies, as applicable.

Conocimientos

Planning

Leadership

Cross-functional collaboration

Quality mindset

Educación

Bachelor's degree in Chemistry/Biology/Microbiology/Pharmaceutical Sciences/Biochemistry

Herramientas

LIMS

Stability management systems

eQMS

Microsoft Office

Descripción del empleo

Piramal Pharma Solutions (PPL) is seeking a Stability Program Supervisor to lead compliant, timely execution of the site Stability Program. You will supervise Stability personnel, coordinate cross-functional work, and ensure regulatory and customer commitments are met.

Responsibilities include planning, data review, trend analysis, and ensuring inspection readiness while maintaining traceability and adherence to cGMP and QA expectations.