Stability Program Supervisor

Job description

Be the First to Apply Division Piramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation. Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com Job Title Stability Program SupervisorJob Description The Stability Program Supervisor leads the compliant and timely execution of the site Stability Program, including study initiation, sample management, chamber storage, scheduled pulls, testing coordination, data review, trending, investigations, reporting, and study closure. Reporting to the Associate Director, QC Laboratory, this role supervises Stability personnel, coordinates cross-functional execution, maintains inspection readiness, and ensures regulatory and customer commitments are achieved.Core ResponsibilitiesStability Program ExecutionOwn 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. 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. Planning, Coordination & DeliveryTranslate stability requirements into weekly and monthly plans aligned with QC Chemistry and Microbiology capacity. Confirm analyst, instrument, method, reference standard, column, reagent, and sample readiness before scheduled testing. Prioritize work based on regulatory commitments, product risk, customer requirements, and procedural due dates. Monitor active studies, upcoming pulls, testing status, overdue work, report deadlines, and chamber capacity; initiate recovery plans when commitments are at risk. Translate stability requirements into weekly and monthly plans aligned with QC Chemistry and Microbiology capacity. Confirm analyst, instrument, method, reference standard, column, reagent, and sample readiness before scheduled testing. Prioritize work based on regulatory commitments, product risk, customer requirements, and procedural due dates. Monitor active studies, upcoming pulls, testing status, overdue work, report deadlines, and chamber capacity; initiate recovery plans when commitments are at risk. Escalate resource, method, instrument, chamber, sample, or schedule constraints to the Associate Director, QC Laboratory. Data Review, Trending & ReportingEnsure stability results are reviewed for completeness, accuracy, specification compliance, and potential adverse trends. Oversee preparation, technical review, approval, and issuance of interim and final stability reports. Identify and escalate OOT results, shifts, atypical results, and emerging degradation patterns. Provide stability data and assessments for Product Quality Reviews, regulatory submissions, shelf-life evaluations, investigations, and customer requests. Ensure stability results are reviewed for completeness, accuracy, specification compliance, and potential adverse trends. Oversee preparation, technical review, approval, and issuance of interim and final stability reports. Identify and escalate OOT results, shifts, atypical results, and emerging degradation patterns. Provide stability data and assessments for Product Quality Reviews, regulatory submissions, shelf-life evaluations, investigations, and customer requests. Maintain and communicate program metrics, including schedule adherence, testing and report timeliness, backlog, chamber utilization, investigation aging, and right-first-time performance. Chambers, Compliance & Quality SystemsOversee compliant use, monitoring, capacity planning, qualification, calibration, maintenance, alarm response, and contingency planning for stability chambers and controlled storage units. Ensure chamber excursions, alarms, sample discrepancies, OOS/OOT results, deviations, and laboratory events are promptly assessed, documented, investigated, and communicated. Lead or support scientifically sound root cause investigations and effective CAPAs, and monitor quality records through timely closure. Ensure compliance with cGMP, data integrity expectations, applicable FDA regulations, USP requirements, ICH guidance, approved procedures, and customer quality agreements. Oversee compliant use, monitoring, capacity planning, qualification, calibration, maintenance, alarm response, and contingency planning for stability chambers and controlled storage units. Ensure chamber excursions, alarms, sample discrepancies, OOS/OOT results, deviations, and laboratory events are promptly assessed, documented, investigated, and communicated. Lead or support scientifically sound root cause investigations and effective CAPAs, and monitor quality records through timely closure. Ensure compliance with cGMP, data integrity expectations, applicable FDA regulations, USP requirements, ICH guidance, approved procedures, and customer quality agreements. Maintain inspection readiness and support regulatory, customer, and internal audits, including responses and remediation plans. People Leadership & Continuous ImprovementSupervise, coach, develop, and assign priorities to Stability personnel while providing clear expectations and performance feedback. Ensure personnel are trained and qualified, with effective cross-training and backup coverage. Promote ownership, accountability, scientific rigor, teamwork, timely escalation, and a strong quality mindset. Use metrics and trend analysis to reduce backlog, prevent overdue work, improve predictability, and strengthen sample lifecycle, scheduling, review, and reporting processes. Supervise, coach, develop, and assign priorities to Stability personnel while providing clear expectations and performance feedback. Ensure personnel are trained and qualified, with effective cross-training and backup coverage. Promote ownership, accountability, scientific rigor, teamwork, timely escalation, and a strong quality mindset. Use metrics and trend analysis to reduce backlog, prevent overdue work, improve predictability, and strengthen sample lifecycle, scheduling, review, and reporting processes. Support effective use and continuous improvement of LIMS, stability management systems, eQMS, and digital reporting too