Associate Director of Quality Assurance

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

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.

REQUIREMENTS:

SKILLS/KNOWLEDGE AND/OR ABILITIES

• 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

EDUCATION

• Required: Baccalaureate degree in Chemistry, Pharmacy, Biology, or related scientific discipline
• Preferred: Advanced certification in Quality Management, Quality Auditing, or related field

EXPERIENCE

• 10 years experience directly related to pharmaceutical manufacturing and quality assurance operations ideally with at least 5 years of management experience