Senior QA Leader, GxP Compliance & Process Improvement

Boehringer Ingelheim GmbH; Fremont (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Boehringer Ingelheim is seeking a Principal Specialist, Quality Assurance in Fremont, CA. The role leads complex QA activities to ensure systems and processes meet cGMP, regulatory, and customer commitments while driving continuous improvement across BI sites.

As SME and local owner of QA, you will oversee deviations, change controls, CAPA, and validation strategies, partnering with manufacturing to ensure compliance and robust product releases.

Qualifications

• BS/BA in Life Sciences or Engineering required.
• Minimum 7 years of experience in Quality functions in the life sciences.
• Minimum 1 year of experience managing projects in a complex matrix organization.
• Willingness to take a drug test and post‑offer physical (if required).
• Must be legally authorized to work in the United States.

Responsibilities

• Lead QA tasks and ensure audit readiness per GxP requirements.
• Interface with external stakeholders and sign Quality Agreements.
• Oversee deviation and change control processes and training completion.
• Prepare SOPs, work instructions, protocols, templates and Quality Agreements.
• Serve as delegated responsible person for product release when assigned.
• Drive continuous improvement and governance across Boehringer Ingelheim Fremont.

Skills

GxP knowledge

QA leadership

Deviation handling

Regulatory readiness

Data analysis

Cross-functional collaboration

Education

BS/BA in Life Sciences/Engineering

Advanced degree preferred

Minimum 7 years QA experience

Tools

Quality Management System (QMS)

CAPA processes

Job description

Boehringer Ingelheim is seeking a Principal Specialist, Quality Assurance in Fremont, CA. The role leads complex QA activities to ensure systems and processes meet cGMP, regulatory, and customer commitments while driving continuous improvement across BI sites.

As SME and local owner of QA, you will oversee deviations, change controls, CAPA, and validation strategies, partnering with manufacturing to ensure compliance and robust product releases.