Finished Product & Stability QC Senior Manager

Cipla; Town of Islip (NY); On-site; USD 150,000 - 210,000; Full time

Job summary

Cipla in Central Islip, NY seeks a Senior Manager, Quality Control to lead analytical testing and stability programs for Finished Product, ensuring cGMP, FDA, USP, ICH, and data integrity compliance. This role supervises and mentors laboratory staff and partners with QA, Manufacturing, Regulatory Affairs, and Supply Chain to meet product quality and regulatory expectations.

The role requires hands-on QC leadership, deep chromatography knowledge (HPLC/UPLC/GC/IC), and experience with laboratory

Qualifications

• 5+ years in pharmaceutical Quality Control with 3–5 years in a supervisory or managerial role
• Experience supporting FDA-regulated pharmaceutical manufacturing environments
• Hands-on experience with Finished Product and Stability testing in a QC lab
• Strong knowledge of chromatographic techniques and impurity profiling
• Proficient in instrument operation, troubleshooting, and method validation/verification

Responsibilities

• Lead Finished Product and Stability testing to support product release and stability programs
• Oversee assay, related substances, chromatographic purity, degradation product testing
• Ensure timely stability pulls, data review, trending and reporting
• Lead investigations (OOS, OOT, deviations) and CAPA implementation
• Review and approve analytical data, records, and reports
• Support method verification/transfer and cleaning validation activities
• Ensure inspection readiness and support regulatory/customer audits
• Supervise and develop laboratory staff; optimize workload and resources
• Collaborate with QA, Manufacturing, Validation, Regulatory, Supply Chain and R&D to meet objectives

Education

Bachelor's or Master’s degree in Chemistry/Pharmaceutical Sciences

Tools

HPLC

UPLC

GC

IC

Empower

LabSolutions

Tiamo

LIMS

ELN

TrackWise

Job description

Cipla in Central Islip, NY seeks a Senior Manager, Quality Control to lead analytical testing and stability programs for Finished Product, ensuring cGMP, FDA, USP, ICH, and data integrity compliance. This role supervises and mentors laboratory staff and partners with QA, Manufacturing, Regulatory Affairs, and Supply Chain to meet product quality and regulatory expectations.

The role requires hands-on QC leadership, deep chromatography knowledge (HPLC/UPLC/GC/IC), and experience with laboratory