Principal QA Specialist – Global Quality Assurance

BoehringerPRD; Fremont (CA); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Boehringer Ingelheim Fremont seeks a Principal Specialist in Quality Assurance to lead key QA functions, ensure audit readiness, and align with regulatory standards across BI platforms. You will own deviation and change controls, sign Quality Agreements, support batch disposition, and drive continuous improvement with site leadership, suppliers, and clients.

The role requires a BS/BA in life sciences or engineering, 7+ years in QA, and comfort with complex matrix environments; advanced degree

Formación

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

Responsabilidades

• Execute tasks per GxP procedures to ensure audit readiness.
• Interface with external stakeholders to defend QA systems and ensure patient safety.
• Act as quality responsible person and escalation point.
• Establish, sign and maintain Quality Agreements and deviation/change controls.
• Prepare SOPs, work instructions, and quality plans; review records and templates.
• Serve as delegated responsible person for product release where assigned.
• Drive continuous improvement and site integration into global platforms.

Conocimientos

Quality Assurance

GxP

Regulatory Compliance

Audits

CAPA

Quality Systems

Educación

BS/BA in Life Sciences/Engineering

Advanced degree preferred

Descripción del empleo

Boehringer Ingelheim Fremont seeks a Principal Specialist in Quality Assurance to lead key QA functions, ensure audit readiness, and align with regulatory standards across BI platforms. You will own deviation and change controls, sign Quality Agreements, support batch disposition, and drive continuous improvement with site leadership, suppliers, and clients.

The role requires a BS/BA in life sciences or engineering, 7+ years in QA, and comfort with complex matrix environments; advanced degree