We are seeking a highly motivated hands-on individual to join us as an Associate Director, Supplier Quality Management (SQM) for contract manufacturing organizations (CMOs), contract test labs (CTLs), third party logistics (3PLs) (couriers, remote warehousing) and Equipment service providers (e.g. calibration, cleaning). You will work with the Quality team in supporting our efforts of improving GRAIL’s Quality Management Systems. This individual will work cross-functionally to execute and further define the SQM program for CMOs, CTLs, 3PLs, and Equipment Management service providers.
- Accountable for the supplier compliance of: Audits, Supplier Quality Agreements (SQA), SCARs, supplier Questionnaires, Supplier Request for Information (RFI), and management of supplier initiated changes.
- Manage cross-functionally (Supply Chain, Process Engineering, Manufacturing, Regulatory Affairs, Clinical laboratory operations, Clinical compliance operations) within GRAIL and externally to assure compliance and strong relationships with the CMOs, CTLs, 3PLs and service providers.
- Collaborate within the Quality team to manage: Supplier qualification and specification development processes that use risk-based tools for qualification, classification and performance monitoring, supplier SQAs process to assure key quality expectations are reflected in the supplier’s operations and updates for changes are managed and distributed to key impacted operations, supplier initiated change notifications, and phase-in appropriate supplier qualification requirements.
- Conduct supplier audits activities to include: Develop an audit plan, prepare audit reports, communicate findings, audit responses, compliance assessment including assessment of compliance risk to support Supply Chain, Manufacturing, Material Management.
- Manage a QA Operations function for disposition, quality issues, change records, protocol review/approvals, etc..
- Assure the audit schedule and approved supplier list are maintained and up-to-date
- Monitor and report on meaningful SQM performance metrics as well as Supplier performance metrics.
- Provide leadership and direction for CMO, lab-related or service provider issues - SCARs, CAPAs, OOS, deviations and change records.
- Collaborate with a cross-functional team to improve processes/share responsibilities to include leading a Supplier Quality Review Board
- Participate as a representative of SQM for various internal project teams as well as joint committee meetings with suppliers, Materials Review Board, ERP implementation team,
- Assure all SQM related quality documentation and records are completed thoroughly and timely to maintain compliance
- Develop or assist in writing and developing quality management system processes, work instructions, and forms in conjunction with suppliers and internal purchasing control requirements.
- Support inspection readiness plans and interact with regulatory agencies during inspections on SQM-related matters, as needed.
- Perform other duties as assigned.