Snr. Supplier Quality Specialist Job at Enigma Search, Alameda County, CA

YzFDQnM0TGg3YnRyNnNURG9UcVAybVJyc2c9PQ==
  • Enigma Search
  • Alameda County, CA

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

Contract work, Remote job,

Similar Jobs

Palo Alto Networks

Director, Technical Partnerships Job at Palo Alto Networks

 ...Technical Partnerships team within the Global Ecosystems organization to drive global sales and business development initiatives for the Dell Technologies partnership. The ideal candidate will have extensive experience in defining and scaling OEM sales processes across... 

LaSalle Network

Senior Data Engineer Job at LaSalle Network

 ...Job Title: Senior Data Engineer Location: Omaha, NE Employment Type: Contract Job Summary: As a Senior...  ...hire faster and connect top talent with opportunities, from entry-level positions to the C-suite. With units specializing in Accounting... 

Citizens for Responsibility and Ethics in Washington (CREW)

Paralegal Job at Citizens for Responsibility and Ethics in Washington (CREW)

 ...equitable and accountable government, while working alongside smart, dedicated and kind...  ...splitting their time between working at home and working in the office. The Paralegal...  ...~ Free in-office lunches weekly ~ Free virtual yoga classes How to Apply Please... 

Russell Tobin

Executive Assistant (Financial Services/Banking) Job at Russell Tobin

 ...Executive Administrative Assistant Contract Role (12 Months, possible to extend or convert) Pay Range: $30-$31/hour (under negotiation in case of converting or extention) Banking & Financial Industry Location: NYC Were seeking a highly organized Executive... 

AiLO Logistics

Class A Driver- Home Daily Job at AiLO Logistics

 ...Truck Drivers Dream Job! Why join AiLO Logistics Family?-AiLO believes...  ...Service. ~ Regular schedules for local destinations. ~24/7...  ...for drivers. ~ Consistent home time! Yes, you can plan on it...  ...-6493 Qualifications: Class A License, minimum 2 years experience...