Principal Specialist, Quality Systems, Product Summary Reports

our future employee; Saint Joseph (MO); On-site; USD 90,000 - 120,000; Full time

Job summary

Boehringer Ingelheim is seeking a Principal Specialist, Quality Systems, Product Summary Reports to manage annual product reviews and related data analysis. The role also handles product quality complaints, investigations of deviations, and KPI reporting to site management.

The position requires a Bachelor's degree in a scientific field and 8+ years of GxP experience, with strong regulatory knowledge and cGMPs.

Qualifications

• Bachelor's degree in a relevant scientific field with 8+ years of GxP experience.
• Work experience in a regulated GxP industry is required.
• Deep understanding of regulatory and corporate requirements, cGMPs, technical writing and root cause analysis.

Responsibilities

• Independently prepares annual product reviews and data trend analysis.
• Assist with audits to ensure compliance with regulations and guidance documents.
• Lead projects and align priorities with corporate and functional goals.
• Track and complete product quality complaints and logistic deviations in the electronic system.
• Manage the quality system for annual product reviews, product quality complaints, and logistic deviations.
• Develop and maintain KPIs and monthly reports; lead continuous process improvements.

Skills

GxP experience

Regulatory knowledge

cGMPs

Technical writing

Root cause analysis

Education

Bachelor's degree in science

Job description

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).