Quality Systems Manager

1 week ago


Indianapolis IN, United States Harba Solutions Inc. Full time

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


  • Quality System Manager

    19 hours ago


    Indianapolis, IN, United States Harba Solutions Inc. Full time

    Key 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...


  • Indianapolis, United States Harba Solutions Inc. Full time

    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...


  • Indianapolis, United States Harba Solutions Inc. Full time

    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...


  • Indianapolis, United States Harba Solutions Inc. Full time

    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...


  • Indianapolis, United States Langham Logistics Full time

    The 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...

  • Quality Manager

    3 weeks ago


    Indianapolis, IN, United States Mortenson Full time

    SUMMARY Mortenson is currently seeking an experienced Quality Manager with the ability to interact with a variety of staff at all levels in an ever-changing environment, remaining flexible, resourceful, proactive, and efficient with a high level of professionalism and confidentiality. Aptitude to anticipate problems, critical issues, and opportunities as...


  • Indianapolis, IN, United States Mortenson Full time

    SUMMARY Mortenson is currently seeking an experienced Senior Quality Manager to lead, manage, document, monitor, and analyze the quality system on one or more significant projects; and lead necessary corrective and preventive actions. RESPONSIBILITIES Incorporate and lead Mortensons quality system on one or more significant projects: Lead planning,...


  • Indianapolis, IN, United States Mortenson Full time

    SUMMARY Mortenson is currently seeking an experienced Senior Quality Manager to lead, manage, document, monitor, and analyze the quality system on one or more significant projects; and lead necessary corrective and preventive actions. RESPONSIBILITIES Incorporate and lead Mortensons quality system on one or more significant projects: Lead planning,...


  • Indianapolis, Indiana, United States Indotronix Avani Group Full time $120,000 - $180,000 per year

    Title: 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...

  • Quality Manager

    3 weeks ago


    Indianapolis, IN, United States Harba Solutions Inc. Full time

    Job 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...