Senior Global Quality & Compliance Leader

Boehringer Ingelheim; Ridgefield (CT); On-site; USD 167,000 - 250,000; Full time

Job summary

Boehringer Ingelheim in the United States is seeking a Senior Global Quality and Compliance Lead to drive quality strategy, ensure regulatory alignment, and lead CAPA programs across Medicine functions. The role emphasizes proactive compliance, cross-functional collaboration, and data-driven risk assessment to support clinical development projects and inspections.

Ideal candidates bring extensive GxP experience, strong project management, and a record of guiding large teams through regulatory

Qualifications

• Bachelor’s degree and/or Master’s degree (e.g. MBA, MSc).
• Minimum of twelve (12) years in pharmaceutical / CRO industry.
• Minimum of seven (7) years’ experience in Clinical Operations and/or other BI Medicine functions.
• Minimum of five (5) years’ experience in Non-Compliance (NC) and CAPA management processes.
• Eight-plus (8+) years of experience in GxP quality management system.
• Experience interacting with Regulatory Authorities e.g. regulatory inspections.
• Strong interpersonal, cultural, and communicational skills.
• Solution oriented and strong project management skills.

Responsibilities

• Defines and delivers training for NC/CAPA process and other compliance topics as applicable.
• Acts as cross-functional compliance expert: Provides GxP guidance as required; Shares best practices within QM and Medicine functions; Updates process descriptions and guidelines.
• Supports global quality issues, compliance topics and improvement initiatives: performs root cause analysis and identifies CAPAs; ensures effectiveness checks after actions; supports QA tools and methods.
• When assigned: supports IDE projects by assessing GCP compliance; supports partnering projects when BI's GCP compliance is assessed by external partners.
• If/when assigned to a Therapeutic Area: defines strategy for clinical development support; provides trending/analysis; makes recommendations based on risk assessments.

Skills

GxP quality management

CAPA management

Root Cause Analysis

Regulatory interactions

Quality compliance

Project management

Cross-functional collaboration

Communication skills

Travel readiness

Education

Bachelor's degree

Master's degree

Job description

Boehringer Ingelheim in the United States is seeking a Senior Global Quality and Compliance Lead to drive quality strategy, ensure regulatory alignment, and lead CAPA programs across Medicine functions. The role emphasizes proactive compliance, cross-functional collaboration, and data-driven risk assessment to support clinical development projects and inspections.

Ideal candidates bring extensive GxP experience, strong project management, and a record of guiding large teams through regulatory