Quality System Manager

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

A pharmaceutical solutions company located in Indianapolis is seeking a Quality Manager to develop and maintain a compliant Quality Management System (QMS). The role requires overseeing document control and audits, ensuring compliance across storage and distribution activities, and handling investigations and CAPA. Candidates should have extensive experience in quality or compliance within pharmaceutical manufacturing and strong knowledge of relevant regulations. A bachelor's degree in a related field is required, with an advanced degree preferred.

Qualifications

• 5+ years of quality or compliance experience within pharmaceutical manufacturing.
• Strong knowledge of cGMP, GDP, FDA, and ICH regulations.
• Experience managing quality systems, audits, and regulatory inspections.

Responsibilities

• Develop and maintain a compliant Quality Management System (QMS).
• Oversee document control, change management, and CAPA activities.
• Conduct and manage internal audits and coordinate customer audits.
• Ensure compliance across all pharmaceutical storage and handling activities.
• Monitor temperature-controlled shipments and validate equipment.
• Review investigations, deviations, and nonconformances.

Skills

Quality Management Systems

cGMP knowledge

Regulatory compliance

Root cause analysis

Auditing

Education

Bachelor’s degree in Life Sciences or related field

Job description

Direct message the job poster from Harba Solutions Inc.

• 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

Qualifications

• 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
• Strong knowledge of cGMP, GDP, FDA, and ICH regulations
• Experience managing quality systems, audits, and regulatory inspections