Principal Specialist, Quality Systems, Product Summary Reports

Description

The position is responsible for preparation and managing the the annual product reviews quality system. This individual will prepare and/or evaluate data for trends associated to the annual product reviews. This position is also responsible for managing the product quality complaint quality system and investigating product quality complaints and logistic deviations. The position is also responsible for approving all site Corrective Action ' Preventative Action plans, and compiling KPIs for site management. 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.

This is a BI Contract role effective for 12 months - December 2026 - December 2027

Duties & Responsibilities

• Independently prepares the annual product reviews and data trend analysis. Ensures all other areas that contribute to the annual product review process provides the required data prior to the due date.


• Assist with internal, regulatory or Corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.


• Lead projects and ensure department and individual priorities are aligned with corporate, operational and functional priorities.


• Track and complete product quality complaints and logistic deviations in the electronic system. Complete assigned complaint investigations and logistic investigations by due date.


• Responsible for managing the quality system for annual product reviews, product quality complaints, and logistic deviations.


• Development and maintenance of KPIs and applicable monthly reports; manage continuous process improvement initiatives.

Requirements

• Minimum of a Bachelor's degree from an accredited institution in a relevant scientific field with eight-plus (8+) years of GxP experience


• Work experience in a regulated GxP industry required.


• In depth understanding of regulatory and corporate requirements, cGMPs, technical writing and root cause analysis.


• Influencing the understanding of cGMP's, compliance requirements, and regulatory requirements to assess product, procedures, recommended improvements to make quality decisions.

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.