Senior Manager - Quality Control

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Ciplas U.S. Subsidiaries or Affiliates.

Job Title: Senior. Manager, Quality Control

FLSA Classification: Full-Time, Exempt Professional

Work Location: Central Islip, NY (Unit 3)

Work Hours: General Shift: 8:30AM - 5:00PM (may vary based on business needs)

Reports To: Quality Control Director

Salary: $103,000 - $136,000

Position Summary

The Manager, Finished Product & Stability Quality Control is responsible for leading all analytical testing, stability program execution, laboratory compliance activities, investigations, and personnel management associated with Finished Product and Stability testing. The role ensures compliance with cGMP, FDA, ICH, USP, Data Integrity, and internal quality requirements while supporting product release, stability commitments, regulatory inspections, and continuous improvement initiatives.

Key Responsibilities

• Manage Finished Product and Stability testing activities to support commercial product release and ongoing stability programs.
• Oversee testing and review of assay, related substances, chromatographic purity, degradation products, dissolution, content uniformity, residual solvents, and other compendial requirements.
• Ensure timely execution of stability sample pulls, testing, data review, trending, and reporting activities.
• Lead laboratory investigations including OOS, OOT, deviations, atypical results, and CAPA implementation.
• Review and approve analytical data, laboratory records, chromatograms, and technical reports.
• Support method verification, method transfer, process validation, cleaning validation, and troubleshooting activities.
• Ensure inspection readiness and actively support regulatory and customer audits.
• Supervise, train, mentor, and develop laboratory personnel while ensuring efficient workload distribution and resource utilization.
• Partner with QA, Manufacturing, Validation, Regulatory Affairs, Supply Chain, and R&D to meet business and compliance objectives.

Required Qualifications & Experience

• Bachelors or Masters Degree in Chemistry, Pharmaceutical Sciences, or related scientific discipline.
• Minimum 5+ years of pharmaceutical Quality Control experience with at least 3-5 years in a supervisory or managerial role.
• Strong experience supporting FDA-regulated pharmaceutical manufacturing environments.

Technical Knowledge & Competencies

• Hands-on experience in Finished Product and Stability sample testing within a pharmaceutical Quality Control laboratory. Experience with Raw Material testing is preferred.
• Strong knowledge of chromatographic techniques including assay testing, related substances (impurity profiling), degradation product analysis, and chromatographic purity determination using HPLC, UPLC, GC, and IC systems.
• Proficient in operation, troubleshooting, and lifecycle management of analytical instruments including HPLC, UPLC, GC, IC, Dissolution Testers, Karl Fischer, FTIR, UV-Vis, and XRPD.
• Thorough understanding of Oral Solid Dosage (OSD) product testing requirements and regulatory expectations.
• Strong technical expertise in pharmaceutical analytical methodologies, laboratory investigations, data review, and compliance-driven laboratory operations.
• Working knowledge of cGMP, GLP, GDP, Data Integrity requirements, USP, ICH guidelines, and FDA expectations.
• Experience with chromatography data systems and laboratory software including Empower, LabSolutions, Tiamo, and other computerized laboratory systems.
• Working knowledge of Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebook (ELN), and Quality Management Systems such as TrackWise.
• Demonstrated experience in method execution, method troubleshooting, data review, technical assessments, and investigation management.
• Experience supporting regulatory inspections and customer audits, including USFDA, customer, and corporate audits.
• Strong leadership, communication, documentation, decision-making, and problem-solving skills with the ability to effectively manage teams and collaborate across functions.

GLOBAL COMPANY

Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.

Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)

About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

EEO Statement

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.