Stability Program Supervisor

Piramal Critical Care, Inc.; United States; Hybrid; USD 120,000 - 160,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Stability Program Supervisor to lead the site stability program, ensure timely testing, data review, and regulatory readiness. You will coordinate cross-functional teams and manage documentation against quality agreements and regulatory commitments.

The role requires hands-on supervision, planning expertise, and strong collaboration with QC Chemistry, Microbiology, Regulatory Affairs, and Manufacturing to sustain product quality and program integrity.

Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline; advanced degree or certification preferred.
• Minimum 5 years of pharma/biotech/CDMO Quality Control experience in a cGMP lab.
• Experience coordinating stability studies, sample pulls, testing, data review and study closure.
• Experience supervising or leading teams in a quality-control context.
• Working knowledge of cGMP, FDA regulations, USP requirements, ICH stability guidance, data integrity.

Responsibilities

• Own stability program execution with compliant, timely activities and regulatory alignment.
• Maintain the Master Stability Schedule for initiation, pulls, testing, review and closure.
• Oversee sample receipt, labeling, storage, inventory, and traceability with complete records.
• Coordinate studies across commercial, registration, validation, and customer programs as applicable.
• Lead investigations, CAPAs, and quality records closure; ensure inspection readiness.

Skills

Strong planning

Technical writing

Investigation

Problem-solving

Leadership

Communication

Cross-functional collaboration

LIMS

eQMS

Microsoft Office

Education

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

Tools

LIMS

eQMS

Microsoft Office

Job description

Division
Piramal Pharma Solutions
Piramal 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 Supervisor
Job 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.

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 elevate 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 elevate 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 elevate 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 elevate 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.