Head of Quality Assurance & Regulatory Compliance

Germer International; Omaha (NE); On-site; USD 140,000 - 200,000; Full time

Job summary

Germer International seeks a Director of Quality Assurance to oversee all QA activities and ensure compliance with FDA, cGMP, and related regulations across facilities responsible for drug development, manufacture, and distribution.

The role requires deep regulatory knowledge, extensive auditing experience, and the ability to lead cross-functional teams, train staff, and respond to FDA inspections with timely, accurate actions.

Qualifications

• Education: Baccalaureate degree in Chemistry or Pharmacy
• Experience: 10 years experience directly related to pharmaceutical manufacturing and quality assurance operations
• Licensing/Certification: Quality Assurance Certification preferred
• Strong regulatory compliance knowledge and ability to interact with FDA and other agencies

Responsibilities

• Review and develop protocols for conducting tests or validation techniques necessary for approval of facilities or products
• Plan and execute Quality Assurance strategies and procedures to assure compliance with regulatory requirements
• Define and direct corporate quality policies, qualifications, and validations
• Develop, direct, monitor, evaluate, document, and communicate quality assurance program
• Respond in a timely manner to inspection reports, such as FDA Form 483 and develop responses within two weeks
• Assist Regulatory Affairs and Quality Control to diligently prepare annual drug reviews
• Investigate customer complaints
• Work on special projects as assigned
• Maintain work areas in a neat and orderly manner

Skills

Regulatory knowledge

Auditing experience

Regulators liaison

Leadership

Quality systems

Statistical analysis

Laboratory procedures

Documentation

Training

Education

Bachelor in Chemistry or Pharmacy

Advanced degree preferred

Job description

Germer International seeks a Director of Quality Assurance to oversee all QA activities and ensure compliance with FDA, cGMP, and related regulations across facilities responsible for drug development, manufacture, and distribution.

The role requires deep regulatory knowledge, extensive auditing experience, and the ability to lead cross-functional teams, train staff, and respond to FDA inspections with timely, accurate actions.