Director of QA Investigations & Compliance

Germer International - Pharmaceutical Recruiting; Omaha (NE); On-site; USD 140,000 - 180,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting seeks an Associate Director or Director of QA to lead quality assurance investigations, deviations and CAPA activities, ensuring compliance with FDA, cGMP, and company procedures.

The role emphasizes strong investigation and report writing, oversight of quality systems and document control, and coordination of internal audits to support continuous improvement within Quality Operations.

Qualifications

• Requires Baccalaureate degree in a scientific field
• Advanced certification in Quality Management or Quality Auditing preferred
• 10 years experience in pharmaceutical QA operations with 5+ years in management

Responsibilities

• Lead QA investigations and write high-impact reports
• Oversee CAPA, deviations, change controls, and complaints
• Coordinate internal audits and regulatory inspections
• Ensure data integrity and continuous improvement of Quality Operations

Skills

FDA investigations

CAPA management

Root cause analysis

Quality systems

Change control

Document control

Audit preparation

Regulatory communication

QMS software

Education

Baccalaureate degree in Chemistry/Pharmacy/Biology

Quality Management/Quality Auditing certification

Tools

Quality Management Systems (QMS)

Document management software

Job description

Germer International - Pharmaceutical Recruiting seeks an Associate Director or Director of QA to lead quality assurance investigations, deviations and CAPA activities, ensuring compliance with FDA, cGMP, and company procedures.

The role emphasizes strong investigation and report writing, oversight of quality systems and document control, and coordination of internal audits to support continuous improvement within Quality Operations.