Quality Assurance Manager

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a dedicated Quality Assurance Manager to oversee and enhance manufacturing quality operations. This role involves supervising quality support, guiding team members in sterile operations, and implementing rigorous quality systems. The ideal candidate will have extensive experience in regulated environments, a strong understanding of quality principles, and a passion for fostering compliance and continuous improvement. Join a forward-thinking company where your expertise will drive impactful changes and ensure the highest standards of quality across production processes.

Qualifications

• 8+ Jahre Erfahrung in einer QA-Rolle in einem regulierten Produktionsumfeld.
• Mindestens 5 Jahre in einer Führungs- oder Aufsichtsfunktion.

Responsibilities

• Überwachung der Qualitätssicherung in der Fertigung und Sicherstellung der richtigen Personalbesetzung.
• Leitung von Untersuchungen zu Abweichungen und Produktqualitätsproblemen.

Skills

Qualitätsmanagement

Führungskompetenz

Dokumentationsprüfung

Problemlösungsfähigkeiten

Teamentwicklung

Education

Bachelor-Abschluss in Lebenswissenschaften oder Ingenieurwesen

Tools

Digitale Tools für die Dokumentation

Job description

Job Responsibilities

• Oversee quality support for manufacturing operations, ensuring proper staffing and seamless integration of quality oversight throughout production activities.
• Supervise batch record reviews and ensure timely identification and resolution of documentation issues during manufacturing processes.
• Guide and develop team members on core quality practices including sterile operations, gowning procedures, cleanliness standards, and equipment readiness.
• Collaborate cross-functionally to align quality activities with production timelines while maintaining rigorous quality expectations.
• Implement clearance procedures to support start-up and shutdown of critical production spaces, ensuring readiness for each phase of operations.
• Lead investigations into deviations and product quality issues, applying structured problem-solving tools and driving sustainable corrective actions.
• Reinforce a culture of compliance through routine observation, coaching, and engagement with safety and operational teams.
• Ensure data accuracy and compliance by managing documentation workflows and contributing to the maintenance of internal quality systems.
• Stay informed on current trends in quality assurance and regulatory expectations to inform ongoing improvements and ensure sustained compliance.

Qualifications

• Bachelor’s degree in a life science, engineering, or related technical field.
• 8+ years of experience in a QA role within a regulated manufacturing or production environment.
• Minimum of 5 years in a leadership or supervisory capacity overseeing quality or compliance-focused teams.
• Deep understanding of sterile production principles, contamination control, and risk-based quality decision-making.
• Strong working knowledge of industry regulations and experience implementing quality systems and process controls.
• Proficient in reviewing documentation, supporting investigations, and utilizing digital tools for recordkeeping and data analysis.
• Skilled in coaching, team development, and cross-functional collaboration.