Senior Manager, QA Validation and Supplier Quality

We seek a Senior Manager QA Validation and Supplier Quality to oversee the QA Validation and Supplier Quality programs as a Quality Assurance (QA) team member. This leader will oversee the supplier quality program, internal & external audit, and validation programs for the manufacturing and testing site. Reporting to the Director of Quality Assurance, this position will provide quality oversight of material suppliers. It will serve as the Quality Lead for specific Supplier Categories (e.g., Single Use Systems). The individual will also implement the internal audit and data integrity programs in this position. Additionally, the role will provide direction for the QA Validation program at the Metagenomi site.

You will have the opportunity to make a lasting impact as you partner with other cross-functional groups (e.g., Quality Control, Analytical Science, Process Engineering, Process Development, Manufacturing, and Research) to ensure that Metagenomi’s ongoing manufacturing and development programs maintain regulatory compliance with local, state, federal, and international health authority requirements. This role will be based in Emeryville, California.

How you’ll contribute: 

• Oversee the Supplier Quality and QA Validation programs.
• Implement Metagenomi’s supplier quality program (Master Validation Plan) and procedures. 
• Implement Metagenomi’s site-specific Qualification and Validation program, including facility, GMP Systems, equipment/instruments, and computerized systems to support the GMP operation of clinical manufacturing.  
• Establish Data Integrity and Quality Risk Management programs.
• Deploy quality risk management principles to ensure appropriate risk mitigation and control at the commodity/material level when approving supplier corrective actions.
• Provide leadership and strategic direction to establish and/or support phase-appropriate validation/qualification programs.
• Maintain the site validation master plan and drive project qualification plans to completion.
• Collaborate with cross-functional teams, including external parties, to establish verification and validation plans for test methods, equipment, processes, and products using appropriate techniques and identification of risks through execution of FMEA and Risk Analysis.
• Review and approve Design Qualifications (DQs), User Requirement Specifications (URS), Configuration Specifications (CS), Design Specifications (DS), Traceability Matrix (TM), Functional Risk Assessments (FRA), Validation Plans & Master Plans, Validation Protocols/Test Plans, Technical Reports, & SOPs.
• Provide supplier quality oversight for qualification of Contract Manufacturing Organization (CMO) and Contract Testing Laboratory (CTL) material suppliers (e.g., media, chemicals & excipients, single-use systems, etc.)
• Work closely with Quality Control, Analytical Science, Process Engineering, Process Development, Manufacturing, and Research groups to select, review, qualify and approve suppliers.
• Manage supplier change notifications or vendor-initiated changes, investigations, and corrective actions.
• Monitor and measure the effectiveness and performance of suppliers by utilizing internal (e.g., deviation trends, OOS) and external signals (e.g., regulatory intelligence, external audits).and provide periodic updates to Senior Leadership.
• Lead internal planning/preparation of supplier audits (qualification, routine, for cause) and, when applicable, regulatory inspections and manage the audit observation responses promptly and effectively.
• Develop and implement processes for supplier management and material management lifecycle and maintain a supplier database.
• Align and negotiate Quality Agreement terms with internal stakeholders and external partners.
• Work with TechOps cross-functional team (Mfg./Facility/Eng./QC) to support the deviation, CAPA, and Change Control associated with facility, equipment, and GxP systems. 
• Support regulatory filing requirements and other regulatory compliance communication.
• Support batch record reviews.
• Provide trend analyses and KPI/metrics to peers and senior management.
• Provide Quality Assurance (QA) oversight to ensure overall GMP compliance of all relevant processes controlled or supported by computerized systems within the Metagenomi Emeryville site.
• Support, implement, facilitate, and/or support Compliance programs, including but not limited to inspection readiness, audit preparation, execution, reporting, and follow-up to any finding in support of GxP Manufacturing and Testing.

What you bring:

• Bachelor’s degree in engineering, biology, biochemistry or closely related technical discipline
• Minimum of eight years relevant experience in a