Senior GMP Supplier Quality Lead (Hybrid, CA)

Bionova Scientific LLC; Fremont (CA); Hybrid; USD 120,000 - 150,000; Full time

Job summary

Bionova Scientific LLC in Fremont, CA is seeking a Sr. QA Specialist, Supplier Quality to join the Quality Assurance Compliance team. The role focuses on supplier qualification, GMP compliance, and supporting client and regulatory audits with strong attention to detail.

The successful candidate will manage supplier quality systems, conduct on-site audits, and drive continuous improvement across procurement and quality functions, in a hybrid work environment.

Qualifications

• Bachelor of Science in a scientific field or equivalent.
• Minimum of 10 years GMP Quality Assurance and Quality Systems experience.
• Experience with ERP and eQMS systems.
• Expertise in data analysis and trend analysis.
• Strong documentation and communication skills; knowledge of GMP regulations (21 CFR 210/211/11, ICH, ANNEX 1).

Responsibilities

• Assess supplier quality systems, manufacturing processes, and capabilities to meet standards.
• Lead on-site supplier audits and manage supplier documentation and quality agreements.
• Coordinate change control, discrepancy management and supplier investigations.
• Prepare for regulatory and client audits, and support self-inspections.
• Compile metrics for quality management reviews and communicate dispositions timely.
• Interface with suppliers and internal teams to drive continuous improvement.

Skills

GMP Knowledge

Quality Systems

Data analysis

Effective communication

Education

Bachelor of Science in a scientific field

Tools

ERP systems

eQMS systems

Job description

Bionova Scientific LLC in Fremont, CA is seeking a Sr. QA Specialist, Supplier Quality to join the Quality Assurance Compliance team. The role focuses on supplier qualification, GMP compliance, and supporting client and regulatory audits with strong attention to detail.

The successful candidate will manage supplier quality systems, conduct on-site audits, and drive continuous improvement across procurement and quality functions, in a hybrid work environment.