Global Quality & Compliance Strategist - CAPA & Inspections

Boehringer Ingelheim Pharmaceuticals, Inc.; United States; Remote; USD 167,000 - 250,000; Full time

Job summary

Boehringer Ingelheim GmbH in the United States is seeking a Senior Global Quality and Compliance Lead to shape quality strategy and ensure continued regulatory readiness across Medicine functions. You will lead cross-functional teams, apply GxP principles, and drive proactive compliance.

The role requires extensive experience in QA, CAPA, NC, and risk assessment, plus strong collaboration with regulators and internal stakeholders.

Qualifications

• 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 Corrective Action / Preventive Action (CAPA) management processes, incl. Root Cause Analysis methodologies.
• Eight-plus (8+) years of experience in GxP quality management system.
• Experience in interacting with Regulatory Authorities e.g. regulatory inspections
• Strong interpersonal, cultural, and communicational skills.
• Solution oriented.
• Strong organizational and project management skills.
• Travel as needed.

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; Ensures sharing of best practices within QM and Medicine business functions as applicable; Initiates updates of relevant process descriptions and guidelines as needed.
• Supports global quality issues, compliance topics and improvement initiatives: Supports teams to perform root cause analyses and identify adequate CAPAs; Ensures adequacy of effectiveness checks after actions; Supports teams with Quality tools and methods; Offers process analysis and optimization capabilities.
• When assigned: Supports IDE projects (In-Depth Evaluation and Due Diligence Process) by assessing GCP compliance; Supports Partnering projects when BI's GCP compliance is assessed by external potential future partners.
• If/when assigned to a Therapeutic Area: Defines and implements strategy for support of clinical development projects; Supports clinical development teams with trending and analysis; Gives recommendations based on risk assessments for continuous improvements.

Skills

GxP quality management

Regulatory inspections

CAPA management

Root Cause Analysis

Quality systems

Cross-functional collaboration

Travel willingness

Education

Bachelor’s or Master’s degree in a relevant field (e.g. MBA, MSc)

Job description

Boehringer Ingelheim GmbH in the United States is seeking a Senior Global Quality and Compliance Lead to shape quality strategy and ensure continued regulatory readiness across Medicine functions. You will lead cross-functional teams, apply GxP principles, and drive proactive compliance.

The role requires extensive experience in QA, CAPA, NC, and risk assessment, plus strong collaboration with regulators and internal stakeholders.