SR Specialist, Commercial Quality

Overview

SR Specialist, Commercial Quality – Boehringer Ingelheim

Responsible for overseeing local quality systems, ensuring compliance, and managing the local Management System Owner (MSO) functions. Contribute to the discovery, development and delivery of our products to patients and customers.

• Perform responsibilities of local Management System Owner (MSO) for assigned quality system(s), including writing and maintaining local procedures, training local personnel, and actively participating in Global MSO Network.
• Perform timely investigations for logistic incidents and deviations.
• Work closely with third parties on resolution of open events and deviations.
• Identify and monitor U.S. trends through system queries, ensure communication, escalation, and resolution; perform review of trends with Senior Management at least annually.
• Track relevant KPI and implement continuous process improvement initiatives.
• Perform duties of Key User for Quality Systems (LOS, GOTrack), writing/maintaining local procedures, training personnel, requesting roles for end users, and serving as local expert and first line of help.
• Ensure U.S. Marketing Site Quality unit and related areas follow BI regulations and all local regulatory requirements (21 CFR 211.198 and 514.80).
• Assist in Batch Acceptance activities and release of finished goods to the U.S. market.

• B.S. degree in life sciences, engineering, or computer science.
• At least four (4) years of experience in the animal health industry or related field.
• Quality or GMP experience preferred.
• Excellent oral and written communication skills.
• Attention to detail in a fast‑paced, high‑volume environment.
• Ability to work independently and in a team environment.
• Strong interpersonal, planning, organization, and initiative skills.
• Scientific expertise to identify and monitor technical product complaint trends across all BIAH product types and species.
• In-depth understanding of regulatory and corporate requirements, cGMPs, technical writing, and root cause analysis.

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post‑offer physical (if required).
• Must be 18 years of age or older.