Senior Compliance & Quality Director — Remote

Boehringer Ingelheim; United States; On-site; USD 167,000 - 250,000; Full time

Job summary

Boehringer Ingelheim is seeking an experienced quality/compliance professional to lead NC/CAPA processes and cross-functional GxP initiatives. This role emphasizes training, regulatory guidance, and collaboration with QM and Medicine functions across global projects.

The position requires extensive experience in pharmaceutical quality systems, regulatory interactions, and proven ability to drive continuous improvements in clinical development and CAPA programs.

Qualifications

• 12+ years in pharmaceutical/CRO with quality focus.
• 7+ years in Clinical Operations or BI Medicine functions.
• 5+ years in NC/CAPA management and CAPA processes.

Responsibilities

• Defines and delivers training for NC/CAPA and compliance topics.
• GxP guidance and sharing best practices within QM and Medicine functions.
• Supports global quality issues, root cause analyses and CAPA identification.
• Offers process analysis and optimization capabilities.
• Supports IDE/partnering projects by assessing GCP compliance.
• Defines and implements strategy for clinical development support and risk-based improvements.

Skills

GxP quality

CAPA management

Root Cause Analysis

Regulatory interactions

Education

Bachelor’s degree

Master’s degree

Job description

Boehringer Ingelheim is seeking an experienced quality/compliance professional to lead NC/CAPA processes and cross-functional GxP initiatives. This role emphasizes training, regulatory guidance, and collaboration with QM and Medicine functions across global projects.

The position requires extensive experience in pharmaceutical quality systems, regulatory interactions, and proven ability to drive continuous improvements in clinical development and CAPA programs.