The QA Supplier Specialist plays a crucial role in ensuring that the raw materials used in the manufacturing of drug products meet the necessary quality standards. This position is responsible for managing project objectives by planning and evaluating activities related to sourcing, qualification, audit, and life-cycle management of suppliers. The QA Supplier Specialist will support various Quality Assurance project initiatives, respond to Regulatory and Partner inquiries, and manage Specifications, as well as audit activities that pertain to Supplier Quality, Quality Management, and Supplier Performance.
Responsibilities
- Lead the qualification, approval, and on-going monitoring of suppliers and contract testing labs (CTL)
- Conduct risk assessments for new and existing suppliers
- Perform on-site and remote audits to assess supplier compliance with GMP, GxP and applicable regulatory requirements (e.g. FDA, EMA, MHRA)
- Ensure accurate and timely qualification of materials.
- Manage and track Supplier Corrective Action Requests concerning raw materials, single use materials, packaging components, etc. Collaborate with internal stakeholders to resolve supplier-related quality issues.
- Draft, negotiate, and maintain quality technical agreements with key suppliers
- Ensure supplier-related changes are managed through appropriate change control processed
- Work closely with internal teams (project teams, manufacturing/MSAT, to ensure timely supply chain operations.)
- Maintain supplier quality documentation including audit reports, qualification files, and performance metrics
- Perform continuous improvement of the program using methodologies such as QRM and Lean.
- Gather, evaluate, and present information/documentation for regulatory inspections and inquiries, as well as partner and internal audits.
- Prepare and complete action plans; implement efficiency, quality, and customer service standards.
- Resolve problems, identify trends, and determine system improvements; implement change within GMP guidelines.
- Maintain project timelines associated with quality assurance initiatives.
Requirements
- 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 in a supplier quality or auditing role.
- Auditor certification preferred (ASQ, CQA. Etc).
- Strong knowledge of quality systems, risk management, and supplier audit practices.
- Demonstrated ability to manage complex supplier networks and work cross-functionally in a fast-paced, regulated environment
- Experience supporting cell and gene therapy preferred
- Previous experience working in a start-up or growth-phase CGT company
- Proven experience may substitute for education requirements.
- Qualifications relevant to the role will determine the level.
$40 - $60 an hour