Senior QA Principal: Quality Systems & Compliance Leader

Boehringer Ingelheim GmbH; Fremont (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Boehringer Ingelheim Fremont is seeking a Principal Specialist, Quality Assurance to lead QA functions, ensure cGMP compliance, and drive continuous improvement across the site. The role emphasizes cross‑functional collaboration, investigations, change control, batch disposition, and regulatory readiness with oversight of the quality management system.

You will possess 7+ years in life sciences QA, a BS/BA, and preferably an advanced degree, mentoring teams, supporting audits, and partnering

Qualifications

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

Responsibilities

• Execute QA tasks per GxP procedures and BI compliance to ensure audit readiness
• Interface with external stakeholders to support patient safety and regulatory compliance
• Lead deviation and change-control responsibilities and ensure timely training
• Prepare and review SOPs, work instructions, protocols, and Quality Agreements
• Serve as delegated responsible person for product release when assigned
• Oversee Batch Disposition quality system and site disposition governance
• Approve or review GMP records and regulatory submissions as needed
• Maintain shopfloor presence during GMP operations for data integrity and compliance
• Drive continuous improvement and KPI reporting across BI sites
• Partner with Manufacturing to drive quality culture and risk mitigation

Skills

Quality Assurance

GxP

Regulatory compliance

Leadership

Stakeholder management

Education

BS/BA in Life Sciences or Engineering

Advanced degree preferred

Tools

Quality Management System

Job description

Boehringer Ingelheim Fremont is seeking a Principal Specialist, Quality Assurance to lead QA functions, ensure cGMP compliance, and drive continuous improvement across the site. The role emphasizes cross‑functional collaboration, investigations, change control, batch disposition, and regulatory readiness with oversight of the quality management system.

You will possess 7+ years in life sciences QA, a BS/BA, and preferably an advanced degree, mentoring teams, supporting audits, and partnering