Senior QA Lead, Supplier Quality & Audits

Asahi Kasei; United States; Hybrid; USD 120,000 - 150,000; Full time

Job summary

Bionova Scientific LLC, part of the Asahi Kasei Group, is seeking a Sr. QA Specialist, Supplier Quality in Fremont, CA. This role focuses on GMP quality, supplier qualification, and managing audits and regulatory readiness within a hybrid work setup.

The candidate will oversee supplier quality programs, interface with vendors, and lead investigations while ensuring compliance with 21 CFR and ICH guidelines. Strong communication and detail orientation are essential.

Qualifications

• Bachelor of Science degree or equivalent in a scientific field.
• Minimum 10 years GMP Quality Assurance and Quality Systems experience.
• Experience with ERP systems and eQMS systems is a must.
• Expertise in data analysis and trend analysis.
• Strong understanding of pharmaceutical manufacturing processes and documentation requirements.
• Excellent written and verbal communication skills.

Responsibilities

• Assess suppliers through reviews of quality systems, processes, and capabilities.
• Interface with suppliers/clients to obtain material documentation and quality agreements.
• Negotiate and maintain quality agreements outlining product specifications and testing requirements.
• Lead change control, discrepancy management, and supplier investigations.
• Lead on-site supplier audits to verify GMP compliance and procedures.
• Identify supplier quality risks and implement mitigation strategies.
• Coordinate inspection readiness and support client/regulatory audits.

Skills

GMP knowledge

Quality systems

Data analysis

Documentation

Communication

Auditing

ERP systems

eQMS systems

Education

Bachelor of Science degree in a scientific field

Tools

ERP systems

eQMS systems

Job description

Bionova Scientific LLC, part of the Asahi Kasei Group, is seeking a Sr. QA Specialist, Supplier Quality in Fremont, CA. This role focuses on GMP quality, supplier qualification, and managing audits and regulatory readiness within a hybrid work setup.

The candidate will oversee supplier quality programs, interface with vendors, and lead investigations while ensuring compliance with 21 CFR and ICH guidelines. Strong communication and detail orientation are essential.