Quality System Manager
2 weeks ago
Key ResponsibilitiesDevelop, implement, and maintain a compliant Quality Management System (QMS) aligned with cGMP, GDP, FDA, and ICH requirementsOversee document control, change management, deviation handling, CAPA, and training programsConduct and manage internal audits, coordinate customer audits, and support regulatory inspectionsEnsure compliance across all pharmaceutical storage, handling, and distribution activities, including cold chain logistics for biologics and vaccinesMonitor and ensure the integrity of temperature-controlled shipments, including validation of storage and transportation equipmentReview and approve investigations, deviations, nonconformances, and customer complaints, including root cause analysis and corrective actionsMaintain quality performance metrics and prepare management review reports to monitor system effectivenessPartner with operations, warehouse, and client service teams to ensure adherence to GDP and cold chain requirementsReview and approve SOPs, validation protocols, and quality agreementsEnsure all associates receive appropriate quality and compliance trainingSupport continuous improvement initiatives to drive operational excellence and regulatory complianceQualificationsBachelor’s degree in Life Sciences, Quality Management, Engineering, or a related field (advanced degree preferred)5+ years of quality or compliance experience within pharmaceutical manufacturingStrong knowledge of cGMP, GDP, FDA, and ICH regulations Experience managing quality systems, audits, and regulatory inspectionsProven ability to interpret and apply regulatory requirements in a regulated logistics environmentExcellent communication, leadership, and problem-solving skillsProficiency with QMS software and standard business tools
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Quality System Manager
7 hours ago
Indianapolis, United States Harba Solutions Inc. Full timeKey ResponsibilitiesDevelop, implement, and maintain a compliant Quality Management System (QMS) aligned with cGMP, GDP, FDA, and ICH requirementsOversee document control, change management, deviation handling, CAPA, and training programsConduct and manage internal audits, coordinate customer audits, and support regulatory inspectionsEnsure compliance across...
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Quality System Manager
2 weeks ago
Indianapolis, United States Harba Solutions Inc. Full timeKey ResponsibilitiesDevelop, implement, and maintain a compliant Quality Management System (QMS) aligned with cGMP, GDP, FDA, and ICH requirementsOversee document control, change management, deviation handling, CAPA, and training programsConduct and manage internal audits, coordinate customer audits, and support regulatory inspectionsEnsure compliance across...
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Quality System and Compliance Manager
7 days ago
Indianapolis, United States Langham Logistics Full timeThe Quality System and Compliance Manager is responsible for overseeing quality and compliance activities for Langham Logistics supporting the pharmaceutical industry, including biologics, vaccines, and general pharmaceutical products. This role ensures all operations meet regulatory requirements, client expectations, and company standards while maintaining...
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Quality System Manager
19 hours ago
Indianapolis, IN, United States Harba Solutions Inc. Full timeKey Responsibilities Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience. Develop, implement, and maintain a compliant Quality Management System (QMS) aligned with cGMP, GDP, FDA, and ICH requirements Oversee document control, change management, deviation handling, CAPA, and training programs...
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Quality System Engineer
2 weeks ago
Indianapolis, Indiana, United States Indotronix Avani Group Full time $120,000 - $180,000 per yearTitle: Sr. Systems Quality EngineerLocation: Indianapolis, IN 46219Full Time JobRate: ($150k per annum)Background in Systems Quality and/or Continuous Improvement EngineeringExperience leading with RCCA methodology (8D, Fault Tree, Fishbone/Ishikawa, etc.) and FRACAS management.You will own the quality strategy across the full system lifecycle—from concept...
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Quality Systems Associate
4 days ago
Indianapolis, United States Grifols Full timeWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
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Quality Systems Associate
2 days ago
Indianapolis, IN, United States Grifols Shared Services North America, Inc Full timeWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
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Quality Systems Manager
1 week ago
Indianapolis, IN, United States Harba Solutions Inc. Full timeDevelop, implement, and maintain a compliant Quality Management System (QMS) aligned with cGMP, GDP, FDA, and ICH requirements Oversee document control, change management, deviation handling, CAPA, and training programs Conduct and manage internal audits, coordinate customer audits, and support regulatory inspections Ensure compliance across all...
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Computer Systems Quality Assurance
1 week ago
Indianapolis, Indiana, United States Ampstek Full timeRole: Computer Systems Quality Assurance (CSQA)Location: Indianapolis-RemoteJob Type : Long Term ContractJob Description:(Roles and Responsibilities)This Computer Systems Quality Assurance role will be responsible for supporting the expansion of client's ERP systems and associated applications to new and existing manufacturing sites. The role will deliver...
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PR&D Quality Systems
2 weeks ago
Indianapolis, Indiana, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
