Quality & Compliance Leader, Regulated QA & Global Impact

Boehringer Ingelheim GmbH; Saint Joseph (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

Boehringer Ingelheim GmbH is seeking a senior Quality Assurance Manager to oversee QA operations for release of components, raw materials and products in a regulated environment.

You will lead audits, CAPA, deviations, complaints handling, validation reviews and change control, while ensuring alignment with FDA, EU, and BI standards. The role involves budgeting, staffing, and driving quality improvements across the department.

Qualifications

• Bachelor's degree in a scientific field; advanced degree preferred.
• Minimum eight years in regulated QA with leadership experience.

Responsibilities

• Manages overall operation of the QA department.
• Oversees budgeting and cost control for QA activities; manages headcount and performance reviews.
• Ensures compliance with cGMP/GLP, FDA, and BI requirements; develops and implements SOPs and QA procedures.
• Reviews and approves deviations, validation documentation, and related QC records.
• Leads audits, CAPA, complaints handling, and change control; maintains documentation integrity.

Skills

Leadership

Regulatory knowledge

Communication

Data interpretation

Education

Bachelor's Degree in scientific discipline

Advanced degree

Tools

QA systems

Job description

Boehringer Ingelheim GmbH is seeking a senior Quality Assurance Manager to oversee QA operations for release of components, raw materials and products in a regulated environment.

You will lead audits, CAPA, deviations, complaints handling, validation reviews and change control, while ensuring alignment with FDA, EU, and BI standards. The role involves budgeting, staffing, and driving quality improvements across the department.