Senior Supplier Quality and Compliance QA Lead

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

Job summary

Bionova Scientific LLC is seeking a Sr. QA Specialist, Supplier Quality to lead supplier qualification, audits, and QA compliance programs in Fremont, CA.

The role focuses on GMP practices, supplier documentation, and quality agreement management, with cross-functional collaboration across procurement and QA teams. The ideal candidate has a BS in a science field and 10+ years of GMP QA experience, including ERP/eQMS proficiency and strong data analysis.

Qualifications

• Bachelor of Science in a scientific field required.
• Minimum 10 years GMP QA and Quality Systems experience.
• Experience with ERP and eQMS systems required.
• Strong data/trend analysis skills.
• Excellent written and verbal communication.
• Knowledge of GMP regulations (21 CFR 210/211/11, ANNEX 1, ICH, etc.).

Responsibilities

• Assess potential suppliers through reviews of quality systems, processes and capabilities.
• Interface with internal/external suppliers and clients to obtain documentation and establish quality agreements.
• Negotiate and maintain quality agreements outlining product specs, QC procedures and reporting.
• Handle Change Control activities, discrepancy management and supplier investigations.
• Lead on-site supplier facility audits to verify GMP compliance and documented procedures.
• Identify quality risks and implement mitigation strategies with suppliers.
• Coordinate communications with suppliers, procurement and internal QA teams.
• Enforce QA policies to maintain product quality and compliance.
• Investigate discrepancies and manage corrective actions and CAPA.
• Compile metrics for Quality Management Review and report disposition status.
• Coordinate inspection readiness and support regulatory audits and self-inspections.

Skills

GMP Quality Assurance

Supplier Quality

Data Analysis

Documentation & Reporting

Communication Skills

Independent & Teamwork

Education

BS in Science

Tools

ERP Systems

eQMS

QMS Software

Microsoft Office

Job description

Bionova Scientific LLC is seeking a Sr. QA Specialist, Supplier Quality to lead supplier qualification, audits, and QA compliance programs in Fremont, CA.

The role focuses on GMP practices, supplier documentation, and quality agreement management, with cross-functional collaboration across procurement and QA teams. The ideal candidate has a BS in a science field and 10+ years of GMP QA experience, including ERP/eQMS proficiency and strong data analysis.