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Associate Director of Quality Assurance
Job in
Omaha, Douglas County, Nebraska, 68197, USA
Listed on 2026-10-16
Listing for:
Germer International - Pharmaceutical Recruiting
Full Time
position Listed on 2026-10-16
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers, Data Analyst
Job Description & How to Apply Below
Our client is hiring an Associate Director or Director of QA. This role will provide leadership, management and responsibility for Quality Assurance Investigations and Operational Auditing functions. Ensures all quality-related corrective measures related to investigations, deviations, change controls, CAPAs, and complaints are conducted, documented, and closed in compliance with FDA, cGMP, and company procedures. Provides strong investigation and report writing skills as a lead author of high criticality Quality Assurance reports and investigations.
Oversees quality systems, documentation management, and internal audit coordination to ensure data integrity and continuous improvement within Quality Operations.
- Comprehensive understanding of cGMP regulations and FDA expectations for documentation and investigations
- Demonstrated expertise in deviation investigations, CAPA management, and root cause analysis
- Strong investigation and report writing skills with working knowledge of quality systems, change control, and document control processes
- Experience with audit preparation, management, and follow-up for both internal and regulatory inspections
- Excellent organizational skills and attention to detail in document review and recordkeeping
- Strong analytical and problem-solving abilities with a data-driven approach
- Ability to lead cross-functional teams in investigation and CAPA resolution activities
- Skilled in communication with internal teams, regulatory agencies, and external partners
- Proficiency in use of Quality Management Systems (QMS) and document control software
- Ability to train, coach, and develop personnel in investigation techniques and quality system processes
- Required:
Baccalaureate degree in Chemistry, Pharmacy, Biology, or related scientific discipline - Preferred:
Advanced certification in Quality Management, Quality Auditing, or related field
- 10 years experience directly related to pharmaceutical manufacturing and quality assurance operations ideally with at least 5 years of management experience
Position Requirements
10+ Years
work experience
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