Principal Quality Systems Lead, Product Reviews & KPIs

Boehringer Ingelheim GmbH; Saint Joseph (MO); Vor Ort; USD 110.000 - 140.000; Vollzeit

Zusammenfassung

Boehringer Ingelheim is seeking a Principal Specialist, Quality Systems to manage annual product reviews, CAPA, and KPIs for site quality programs.

You will lead data trend analyses, investigations of product quality complaints and logistic deviations, and support internal audits to ensure cGMP compliance and continuous improvement. This contract role supports a 12-month assignment at the Saint Joseph, MO site with cross-functional collaboration across QA, manufacturing and regulatory affairs.

Qualifikationen

• Bachelor's degree in a relevant scientific field.
• Eight or more years of GxP experience in a regulated industry.
• Strong knowledge of regulatory and corporate requirements, including cGMPs.
• Ability to perform root cause analysis and communicate findings.

Aufgaben

• Independently prepares the annual product reviews and data trend analysis.
• 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.
• 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.

Kenntnisse

GxP experience

Regulatory compliance

cGMP knowledge

Root cause analysis

Technical writing

Ausbildung

Bachelor's degree in a relevant scientific field

Jobbeschreibung

Boehringer Ingelheim is seeking a Principal Specialist, Quality Systems to manage annual product reviews, CAPA, and KPIs for site quality programs.

You will lead data trend analyses, investigations of product quality complaints and logistic deviations, and support internal audits to ensure cGMP compliance and continuous improvement. This contract role supports a 12-month assignment at the Saint Joseph, MO site with cross-functional collaboration across QA, manufacturing and regulatory affairs.