QA Principal Specialist: Quality & Compliance (Fremont)

Boehringer Ingelheim Pharmaceuticals, Inc.; Fremont (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Boehringer Ingelheim Pharmaceuticals, Inc. in Fremont, CA is seeking a Principal Specialist in Quality Assurance to lead key QA functions, ensure regulatory readiness, and drive continuous improvement across systems and processes.

This role emphasizes expert judgment, collaboration with external stakeholders, and ensuring a compliant, inspection-ready Quality Management System. The position requires a BS/BA in Life Sciences or Engineering, 7+ years in QA, and at least 1 year of project

Qualifications

• BS/BA in Life Sciences/Engineering required.
• Advanced degree preferred.
• Minimum of 7 years of experience in Quality functions within the life sciences or a closely related industry.
• Minimum of 1 year of experience managing projects and priorities in a complex matrix organization.

Responsibilities

• Execute tasks (authoring, performing, reviewing) per GxP procedures and BI compliance to ensure audit readiness.
• Interface with external stakeholders to build partnerships and defend the BI Quality System.
• Serve as quality guidance provider to resolve issues and maintain regulatory readiness.
• Own or support implementation of the Batch Disposition quality system and oversee documentation readiness.

Skills

Quality Assurance

GxP

Regulatory knowledge

Process improvement

Project management

Data analysis

Cross-functional collaboration

Education

BS/BA in Life Sciences/Engineering

Advanced degree preferred

Job description

Boehringer Ingelheim Pharmaceuticals, Inc. in Fremont, CA is seeking a Principal Specialist in Quality Assurance to lead key QA functions, ensure regulatory readiness, and drive continuous improvement across systems and processes.

This role emphasizes expert judgment, collaboration with external stakeholders, and ensuring a compliant, inspection-ready Quality Management System. The position requires a BS/BA in Life Sciences or Engineering, 7+ years in QA, and at least 1 year of project