Job Description

Are you a seasoned Quality Assurance professional with a passion for ensuring the highest standards in pharmaceutical manufacturing? Our client, a rapidly growing and innovative Cell & Gene Therapy CDMO in the San Francisco Bay Area, is actively seeking a QA Supplier Specialist to join their dedicated team.

This is a pivotal role where you'll be instrumental in guaranteeing the quality of raw materials essential for groundbreaking drug products. If you thrive in a fast-paced, regulated environment and possess a strong background in supplier quality management and auditing, we want to hear from you!

What You'll Do:

As a QA Supplier Specialist, you'll be at the forefront of ensuring quality throughout the supply chain. Your responsibilities will include:

• Leading the qualification, approval, and ongoing monitoring of crucial suppliers and contract testing labs (CTLs).
• Conducting thorough risk assessments for both new and existing suppliers to proactively manage potential issues.
• Performing on-site and remote audits to rigorously assess supplier compliance with GMP, GxP, and all applicable regulatory requirements (e.g., FDA, EMA, MHRA).
• Ensuring the accurate and timely qualification of all incoming materials.
• Managing and tracking Supplier Corrective Action Requests (SCARs) related to raw materials, single-use materials, and packaging components, collaborating closely with internal teams to resolve any quality issues.
• Drafting, negotiating, and maintaining quality technical agreements with key suppliers.
• Overseeing supplier-related changes through robust change control processes.
• Collaborating closely with internal project teams, manufacturing/MSAT, and other stakeholders to ensure seamless supply chain operations.
• Maintaining comprehensive supplier quality documentation, including audit reports, qualification files, and performance metrics.
• Driving continuous improvement initiatives within the supplier quality program using methodologies like Quality Risk Management (QRM) and Lean principles.
• Gathering, evaluating, and presenting information and documentation for regulatory inspections, inquiries, and internal/partner audits.
• Preparing and completing action plans, and implementing efficiency, quality, and customer service standards within the supply chain.
• Identifying trends, resolving problems, and determining system improvements, implementing changes strictly within GMP guidelines.
• Maintaining critical project timelines for quality assurance initiatives.

What You'll Bring:

We're looking for a highly organized and detail-oriented professional with:

• A Bachelor's degree in engineering, life sciences, logistics, or a related field (Master's or advanced degree preferred).
• 7+ years of quality experience in the pharmaceutical or biotechnology industry, with at least 4 years specifically in a supplier quality or auditing role .
• Auditor certification (e.g., ASQ, CQA) is strongly preferred.
• Strong knowledge of quality systems, risk management, and supplier audit best practices.
• Demonstrated ability to manage complex supplier networks and thrive in a cross-functional, fast-paced, and highly regulated environment.
• Previous experience supporting cell and gene therapy manufacturing is a significant plus.
• Prior experience working in a start-up or growth-phase Cell and Gene Therapy company is highly desirable.
• Proven experience may substitute for education requirements.

Job Tags

Similar Jobs