Stability Program Lead

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

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.