Stability Program Supervisor

• Own day-to-day execution of the site Stability Program in accordance with approved procedures, protocols, specifications, quality agreements, and applicable regulatory requirements.

• 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.
• 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.

• Translate stability requirements into weekly and monthly plans aligned with QC Chemistry and Microbiology capacity.

• 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.
• 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.

• Ensure stability results are reviewed for completeness, accuracy, specification compliance, and potential adverse trends.

• 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.
• 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.

• Oversee compliant use, monitoring, capacity planning, qualification, calibration, maintenance, alarm response, and contingency planning for stability chambers and controlled storage units.

• 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.
• 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.

• 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.
• 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 tools.

• Set daily, weekly, and monthly execution priorities in alignment with QC leadership.

• Set daily, weekly, and monthly execution priorities in alignment with QC leadership.
• Assign Stability team work and coordinate testing and data-review priorities with laboratory leaders.
• Initiate recovery and improvement plans, drive cross-functional follow-up, and escalate material compliance or delivery risks.
• Set daily, weekly, and monthly execution priorities in alignment with QC leadership.
• Assign Stability team work and coordinate testing and data-review priorities with laboratory leaders.
• Initiate recovery and improvement plans, drive cross-functional follow-up, and escalate material compliance or delivery risks.
• Final Quality disposition, regulatory strategy approval, and decisions requiring Quality Unit authority remain with designated functional leadership and Quality Unit approvers.

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline; advanced degree or relevant certification preferred.

• 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.
• 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.

• On-time completion of stability pulls, testing, data review, reports, and regulatory or customer commitments.
• Sustained control of overdue activities and backlog, with improved schedule predictability.
• Timely, scientifically sound closure of investigations, deviations, CAPAs, and chamber excursions.
• Accurate sample inventory, traceable documentation, effective chamber capacity management, and inspection readiness.
• On-time completion of stability pulls, testing, data review, reports, and regulatory or customer commitments.
• Sustained control of overdue activities and backlog, with improved schedule predictability.
• Timely, scientifically sound closure of investigations, deviations, CAPAs, and chamber excursions.
• Accurate sample inventory, traceable documentation, effective chamber capacity management, and i