Senior QA Investigations, CAPA & Audits Leader

Germer International - Pharmaceutical Recruiting; Omaha (NE); On-site; USD 90,000 - 120,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting is looking for a Senior Manager of QA and Operational Audits located in Omaha, Nebraska. The successful candidate will lead quality assurance investigations and oversee operational auditing functions, ensuring compliance with FDA, cGMP, and company procedures.

The role requires a comprehensive understanding of regulations, strong investigation skills, and the ability to lead cross-functional teams. Candidates should possess a degree in a relevant scientific discipline and significant experience in pharmaceutical quality assurance.

Qualifications

• 5-8 years of experience in pharmaceutical quality assurance, including investigation and documentation management.
• 2-5 years of leadership or supervisory experience in a GMP-regulated environment preferred.
• Solid-dose manufacturing experience preferred.

Responsibilities

• Lead QA investigations and operational audits ensuring compliance with FDA and cGMP.
• Oversee quality systems, documentation management, and internal audit coordination.
• Train and develop personnel in investigation techniques and quality system processes.

Skills

cGMP regulations

CAPA management

investigation and report writing

audit preparation

organizational skills

analytical abilities

communication skills

Quality Management Systems (QMS)

Education

Baccalaureate degree in Chemistry, Pharmacy, Biology, or related field

Advanced certification in Quality Management or Quality Auditing

Tools

document control software

Job description

Germer International - Pharmaceutical Recruiting is looking for a Senior Manager of QA and Operational Audits located in Omaha, Nebraska. The successful candidate will lead quality assurance investigations and oversee operational auditing functions, ensuring compliance with FDA, cGMP, and company procedures.

The role requires a comprehensive understanding of regulations, strong investigation skills, and the ability to lead cross-functional teams. Candidates should possess a degree in a relevant scientific discipline and significant experience in pharmaceutical quality assurance.