Stability Program Execution
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.
Planning, Coordination & Delivery
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.
Data Review, Trending & Reporting
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.
Chambers, Compliance & Quality Systems
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.
People Leadership & Continuous Improvement
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.
Cross-Functional Collaboration
Partner with QC Chemistry, QC Microbiology, Quality Assurance, Regulatory Affairs, Manufacturing, Planning, Technical Services, Analytical Development, Project Management, customer teams, Engineering, Metrology, and Facilities to align testing capacity, resolve risks, support investigations, maintain chambers, and deliver regulatory and customer commitments.
Decision-Making & Authority
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.
Qualifications
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.
Measures of Success
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 inspection readiness.
Qualified personnel, resilient backup coverage, and right-first-time stability documentation and reporting.
