SR Specialist, Commercial Quality

Description

This position is responsible for overseeing and maintaining compliance of local quality systems, to ensure local procedures are in place to support these systems, and to assure local personnel is assigned to the appropriate management systems. The Quality Systems will include one or more of the following: Discrepancy Management, Logistic Incidents, Batch Disposition. They will act as the local Management System Owner (MSO). As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. 

Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• Perform responsibilities of local Management System Owner (MSO) for assigned quality system(s), including writing and maintaining local procedures, training local personnel, 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 US trends through system queries and ensure communication, escalation, and resolution. Perform review of trends with Senior Management (Commercial Quality and Commercial Operations) at least annually.
• Track relevant KPI and implement continuous process improvement initiatives.
• Perform duties of Key User for Quality Systems (i.e. LOS, GOTrack), including writing/maintaining local procedures, training local personnel on system use, requesting roles for end users, and being local expert and first line of help for all local end users.
• Ensure US Marketing Site Quality unit and related areas follow BI regulations and all local regulatory requirements (i.e. 21CFR §211.198 and 514.80) for assigned management systems.
• Assist in Batch Acceptance activities and release of finished goods to the US market.

Requirements

• B.S. degree from an accredited institution in life sciences, engineering, or computer science.
• At least four (4) years of experience working in the animal health industry or related field.
• Quality or GMP experience preferred.
• Demonstrates and maintains excellent oral and written communication skills.
• Attention to detail in a fast-paced, high volume environment imperative.
• Ability to work in a team environment and independently.
• Demonstrated interpersonal and communication skills, planning and organization skills, attention to detail, initiative and independent judgment are required.
• Possess the scientific expertise and product knowledge 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.

Eligibility Requirements:

• 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.