Quality & Compliance Leader — Regulatory Excellence & QA Steward

BoehringerPRD; Saint Joseph (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

Boehringer Ingelheim is seeking a QA Leader to manage quality assurance for release of components, raw materials, and products. You will oversee audits, CAPA, deviations, complaints, validation reviews, and change control in a cGMP environment.

The role requires directing QA systems, training, and ensuring compliance with FDA, EU, USDA requirements, while maintaining BI policies and a culture of ethics and quality. This position emphasizes leadership and collaboration across global teams.

Qualifications

• Minimum eight years in regulated industry and QA, including leadership experience.
• Strong knowledge of cGMP/GLP requirements and BI standards.
• Ability to manage large teams and communicate across levels.

Responsibilities

• Oversee overall department operations and budgeting.
• Prioritize work, resolve issues, and implement QA improvements.
• Develop and implement departmental procedures and policies.
• Lead reviews of testing procedures and specifications.
• Ensure SOPs and safety procedures are followed.
• Perform final QA review on deviations, complaints, and validation docs.
• Provide technical guidance and training within the dept.
• Ensure compliance with regulatory and corporate standards.

Skills

Leadership

Interpersonal skills

Communication

Data interpretation

Problem solving

Computer software

Education

Bachelor's degree in science

Job description

Boehringer Ingelheim is seeking a QA Leader to manage quality assurance for release of components, raw materials, and products. You will oversee audits, CAPA, deviations, complaints, validation reviews, and change control in a cGMP environment.

The role requires directing QA systems, training, and ensuring compliance with FDA, EU, USDA requirements, while maintaining BI policies and a culture of ethics and quality. This position emphasizes leadership and collaboration across global teams.