Quality Systems Manager
1 week ago
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
Conduct and manage internal audits, coordinate customer audits, and support regulatory inspections
Ensure compliance across all pharmaceutical storage, handling, and distribution activities, including cold chain logistics for biologics and vaccines
Monitor and ensure the integrity of temperature-controlled shipments, including validation of storage and transportation equipment
Review and approve investigations, deviations, nonconformances, and customer complaints, including root cause analysis and corrective actions
Maintain quality performance metrics and prepare management review reports to monitor system effectiveness
Partner with operations, warehouse, and client service teams to ensure adherence to GDP and cold chain requirements
Review and approve SOPs, validation protocols, and quality agreements
Ensure all associates receive appropriate quality and compliance training
Support continuous improvement initiatives to drive operational excellence and regulatory compliance
Bachelor’s degree in Life Sciences, Quality Management, Engineering, or a related field (advanced degree preferred)
~5+ years of quality or compliance experience within pharmaceutical manufacturing
~ Experience managing quality systems, audits, and regulatory inspections
~ Proven ability to interpret and apply regulatory requirements in a regulated logistics environment
~ Proficiency with QMS software and standard business tools
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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 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
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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
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Quality Manager
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Senior Quality Manager
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Senior Quality Manager
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Indianapolis, IN, United States Harba Solutions Inc. Full timeJob Responsibilities Champions the creation and continuous evolution of a strong quality culture—driving strategy, policy, team objectives, and all warehouse processes that influence Quality Assurance, in partnership with clients. Interprets and applies GxP regulations and policies to complex and often unique operational challenges. Oversees internal and...