Quality & Compliance Leader – GXP & Regulatory

Boehringer Ingelheim; Saint Joseph (MO); On-site; USD 110,000 - 150,000; Full time

Job summary

Boehringer Ingelheim is seeking an experienced QA leader to oversee release quality for components, materials, and products, ensuring adherence to FDA/GLP/good practice standards. The role manages CAPA, deviations, audits, and proper documentation, while guiding trend analysis and continuous improvement.

The candidate will lead a team, drive QA systems, and collaborate across functions to uphold BI's quality commitments and regulatory compliance in a global biopharmaceutical environment.

Qualifications

• Bachelor's degree or advanced degree in a scientific discipline.
• 8+ years in regulated industry and QA, including 3+ years leadership.
• Well versed in cGMP/GLP and BI requirements.
• Ability to manage a substantial team and diverse stakeholders.
• Strong data evaluation, interpretation, and sound recommendations.
• Excellent written and verbal communication.

Responsibilities

• Manage department operations and budget within defined constraints.
• Set priorities, drive QA improvements, and conduct performance reviews.
• Develop and implement procedures and policies for compliance.
• Review and revise testing procedures and specifications.
• Ensure SOPs, safety procedures, and controlled documents are followed.
• Oversee deviations, product complaints, validation docs, and approval processes.

Skills

Leadership

People management

Regulatory knowledge

Quality Assurance

Analytical thinking

Communication skills

Problem solving

Attention to detail

Education

Bachelor's degree

Job description

Boehringer Ingelheim is seeking an experienced QA leader to oversee release quality for components, materials, and products, ensuring adherence to FDA/GLP/good practice standards. The role manages CAPA, deviations, audits, and proper documentation, while guiding trend analysis and continuous improvement.

The candidate will lead a team, drive QA systems, and collaborate across functions to uphold BI's quality commitments and regulatory compliance in a global biopharmaceutical environment.