QA Compliance Lead — Life Sciences

Boehringer Ingelheim; Fremont (CA); On-site; USD 60,000 - 97,000; Full time

Job summary

Boehringer Ingelheim Fremont is seeking a Specialist, Quality Assurance to execute assigned quality activities ensuring cGMP compliance, regulatory standards, and customer commitments. You will collaborate across QA, QC, Operations and MSAT to maintain product integrity and readiness for inspections.

The role supports data collection, trending, CAPA and SOP updates, with opportunities to drive small cross-functional improvements and contribute to site readiness for audits.

Qualifications

• Requires a bachelor’s degree or equivalent with 3+ years in QA/quality-related life sciences roles
• Experience with cGMP, regulatory standards and quality systems
• Familiarity with quality records, CAPA, change control and audits

Responsibilities

• Execute quality activities to ensure compliance with product requirements and cGMP
• Maintain product integrity and alignment with quality systems
• Lead cross-functional continuous improvement initiatives
• Collaborate with Manufacturing, QA, QC and MSAT to improve processes
• Support SOPs, CAPA, data trending and periodic reviews
• Contribute to regulatory submissions and site audits

Skills

Pharma manufacturing

Analytical testing

Quality systems

Regulatory knowledge

Data integrity

Trackwise

SAP/LIMS

Cross-functional

Education

Bachelor's degree

HS diploma +7 years

Tools

SAP

LIMS

Job description

Boehringer Ingelheim Fremont is seeking a Specialist, Quality Assurance to execute assigned quality activities ensuring cGMP compliance, regulatory standards, and customer commitments. You will collaborate across QA, QC, Operations and MSAT to maintain product integrity and readiness for inspections.

The role supports data collection, trending, CAPA and SOP updates, with opportunities to drive small cross-functional improvements and contribute to site readiness for audits.