Principal Specialist, Quality Systems, Product Summary Reports

Boehringer Ingelheim; Saint Joseph (MO); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Job summary

Boehringer Ingelheim in Missouri is seeking a contract role (12 months) to prepare and manage the annual product reviews quality system and data trend analyses. You will also manage product quality complaints and logistic deviations and oversee CAPA plans.

You will lead investigations, ensure regulatory compliance, and develop KPIs for site management, contributing to our global quality objectives and ongoing improvement initiatives.

Qualifications

• Bachelor's degree with 8+ years of GxP experience in a regulated environment.
• Strong understanding of regulatory and cGMP requirements.
• In-depth ability to perform root cause analysis and technical writing.
• Experience developing data trend analysis and KPIs for QA processes.

Responsibilities

• Independently prepares annual product reviews and data trend analysis.
• Assist with audits to ensure regulatory compliance and quality requirements.
• Lead projects aligned with corporate priorities.
• Track and complete product quality complaints and logistic deviations in the system.
• Manage the quality system for annual reviews, complaints, and deviations.
• Develop and maintain KPIs and monthly reporting; drive process improvement.

Skills

GxP experience

Regulatory compliance

Root cause analysis

Technical writing

Data trend analysis

Quality systems

Education

Bachelor's degree in a relevant scientific field

Job description

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

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.

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

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com