MANAGER, QUALITY ASSURANCE

RESPONSIBILITIES:

• Supervise daily warehouse operations to ensure efficient material flow and timely completion of Quality Assurance activities
• Provide oversight of quality systems, including labeling, GMP training, compliance, document control, information tracking, and equipment calibration
• Lead investigation activities, perform root cause analysis, and develop corrective and preventive action (CAPA) plans
• Support internal and external audits and regulatory inspections, ensuring timely resolution and closure of findings
• Develop, maintain, and control document storage and retrieval systems in compliance with GMP requirements
• Review and approve Quality Operations processes, SOPs, and GMP documentation, as applicable
• Utilize statistical process control to analyze quality trends and prepare KPI reports for senior management
• Ensure timely closure and effective management of audit findings
• Prepare QA reports and provide data to support cross-functional business needs
• Oversee management of deviations, CAPAs, and change controls in a timely and compliant manner
• Support customer complaint investigations, ensuring appropriate documentation and resolution
• Supervise, train, and mentor junior QA staff to support team development and capability building
• Ensure full compliance with cGMP regulations and all applicable SOPs
• Experience in Active Pharmaceutical Ingredient (API) environments
• Experience in quality operations within manufacturing, warehouse, and supply chain environments
• Exposure to international supply chain and distribution operations preferred
• Strong knowledge of Quality Systems and GMP compliance requirements
• Hands-on experience with vendor management, customer complaints, deviations, CAPA, change control, and investigations
• Experience supporting internal and external audits and regulatory inspections
• Knowledge of document control systems, GMP training programs, labeling systems, and metrology programs

QUALIFICATIONS:

• Bachelor's degree in a scientific discipline
• 10+ years of experience in Quality Assurance within a GMP-regulated manufacturing environment, or equivalent combination of education and experience
• 5+ years of experience in a supervisory or leadership role within a GMP-regulated manufacturing or distribution environment preferred
• Ability to read and interpret technical procedures, SOPs, GMP regulations, and governmental requirements
• Strong written and verbal communication skills
• Ability to organize, prioritize, and manage multiple tasks with minimal supervision
• High attention to detail and strong analytical skills
• Knowledge of ICH Q7, 21 CFR Part 11, and 21 CFR 210 & 211
• ASQ certifications, ISO 9000 knowledge, or formal audit training preferred.

At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer.

All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.