Quality Assurance Manager - Indianapolis - Harba Solutions Inc.

    Harba Solutions Inc.
    Harba Solutions Inc. Indianapolis

    6 days ago

    Description

    The Quality Assurance Manager is responsible for leading quality systems and ensuring compliance with FDA regulations and GMP standards within a pharmaceutical manufacturing environment. This role oversees QA operations, manages a team, and partners closely with manufacturing, validation, and regulatory groups to ensure safe, compliant, and high-quality drug products.

    Job Responsibilities

    • Lead and develop the Quality Assurance team, including coaching, training, and performance management
    • Oversee GMP quality systems including deviations, CAPAs, change control, complaints, and document control
    • Review and approve batch records, investigations, SOPs, and quality reports
    • Ensure compliance with FDA, cGMP, ICH, and internal quality standards
    • Serve as the primary QA contact during internal audits, FDA inspections, and regulatory audits
    • Partner with manufacturing, validation, QC, and engineering to resolve quality issues and prevent recurrence
    • Support product disposition and lot release decisions
    • Drive continuous improvement initiatives to strengthen compliance and reduce risk
    • Track and trend quality metrics and present findings to site leadership

    Qualifications

    • Bachelor's degree in a scientific or technical field (Chemistry, Biology, Engineering, or similar)
    • 5–8+ years of Quality Assurance experience in a pharmaceutical or GMP-regulated environment
    • 2+ years of people management or leadership experience
    • Strong working knowledge of FDA regulations (21 CFR Parts 210/211)
    • Experience leading or supporting FDA inspections
    • Strong investigation, root cause analysis, and CAPA experience
    • Excellent written and verbal communication skills

    Preferred Qualifications

    • Experience with sterile manufacturing, aseptic processing, or biologics
    • Familiarity with validation, data integrity, and quality risk management (ICH Q9)
    • Experience with electronic QMS and document management systems
    • Lean Six Sigma or continuous improvement certification

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