Stability Program Supervisor

Piramal Pharma•Sellersville, PA

About The Position

The Stability Program Supervisor leads 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. The supervisor oversees stability studies and associated samples, schedules, testing, reports, and records; coordinates laboratory capacity and resources; reviews results and trends; manages chamber readiness and quality-system events; and supports audits and continuous improvement. The role works with QC, Quality Assurance, Regulatory Affairs, Manufacturing, Engineering, Facilities, and other groups to deliver program commitments. Final Quality disposition, regulatory strategy approval, and decisions requiring Quality Unit authority remain with designated functional leadership and Quality Unit approvers.

Requirements

Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline.
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.
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.

Nice To Haves

Advanced degree or relevant certification.
Prior supervisory, team-lead, or program-lead experience.

Responsibilities

Lead 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 completed on time 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; confirm readiness of analysts, instruments, methods, reference standards, columns, reagents, and samples.
Prioritize work based on regulatory commitments, product risk, customer requirements, and procedural due dates; monitor studies, upcoming pulls, testing status, overdue work, reports, and chamber capacity, and initiate recovery plans when needed.
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; oversee preparation, technical review, approval, and issuance of interim and final 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.
Ensure chamber excursions, alarms, sample discrepancies, OOS/OOT results, deviations, and laboratory events are assessed, documented, investigated, and communicated promptly.
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; provide clear expectations and performance feedback, and 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.
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 commitments.
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.
Deliver on-time stability pulls, testing, data review, reports, and regulatory or customer commitments; sustain control of overdue activities and backlog; support timely investigation closure, accurate sample inventory, chamber capacity management, inspection readiness, qualified personnel, and right-first-time documentation and reporting.