Sr. QA Specialist, Supplier Quality

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

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.

Company

Bionova Scientific LLC

Job Description

This Sr. QA Specialist, Supplier Quality is part of the Quality Assurance Compliance team. As a member of the QA team, the role incumbent has GMP Quality experience assessing supplier’s compliance and managing the Bionova Scientific’s (BNS) supplier qualification program. The role also supports Bionova Scientific’s self-inspection program, as well as management of the client audits, health authority inspections, and quality management review. The position requires a high attention to detail, to be organized in their work, strong written and verbal communication skills and working well independently and in a team environment.

Location Fremont, CA

Hybrid – 3-4 days in office a week

Position Responsibilities

• Assessing potential suppliers through thorough reviews of their quality systems, manufacturing processes, and capabilities to ensure they meet required quality standards
• Interface with internal and external suppliers/clients to request/obtain required material and supplier documentation, establish quality agreements as applicable, etc…
• Negotiating and maintaining quality agreements with suppliers, outlining expectations regarding product specifications, quality control procedures, and reporting requirements
• Perform actions associated with Change Control documents, discrepancy management and supplier investigations
• Leading and conducting regular on-site audits at supplier facilities to verify compliance with established Bionova quality requirements, GMP practices, and documented procedures
• Identifying potential quality risks associated with suppliers and implementing mitigation strategies to minimize risks to product quality
• Maintaining open communication with suppliers, procurement teams, and internal quality departments to address quality concerns and drive continuous improvement
• Enforce quality assurance policies and procedures to maintain product quality and compliance
• Investigating and managing discrepancies that may impact product quality, ensuring proper documentation and corrective actions are taken
• Compile metrics for presentation for quality management review and communicate disposition status in a timely manner
• Coordinate the inspection readiness program for Bionova Scientific
• Preparing for and supporting regulatory agency audits, client audits and self-inspection

Working Conditions

This position requires work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 15 pounds independently.

Qualifications

• Bachelor of Science degree or equivalent in a scientific field
• Minimum of 10 years GMP Quality Assurance and Quality Systems experience
• Experience with ERP systems and eQMS systems is a must
• Expertise in data analysis, trend analysis.
• Strong understanding of pharmaceutical manufacturing processes and documentation requirement
• Excellent written and verbal communication skills to effectively document findings and present technical information
• Working knowledge of GMP regulations and guidance (21 CFR 210/211/11, ANNEX 1, ICH, etc.)
• Effective organization and planning skills. Demonstrated ability to deal with frequent changes, delays, or unexpected events
• Effective interpersonal and communication skills. Communication at all management levels and all staff is required
• Proficiency with relevant quality management systems and software

The base compensation range for this role is $120,000-$150,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.