The Role:

ElevateBio is looking for an outstanding candidate to represent Quality on a cross-functional Commercial Readiness team. This role is responsible for supporting commercial readiness gap assessment and mitigation activities to prepare our facility and company for Phase 3/commercial manufacturing for US and EU markets. You’ll work collaboratively with internal subject matter experts and consultants to develop and implement procedural, system, and business process updates according to a defined project plan. Candidates should have extensive experience with manufacturing in a cGMP facility, specifically in later phase assets.

This role will report into the Quality Operations function with dotted line reporting to the Commercial Readiness program lead and team. The successful candidate will initially support Commercial Readiness program activities and will transition to a full-time role within Quality Operations after the implementation of the project is complete (approximately 12 months). Within Quality Operations, the Senior Manager will be primarily responsible for providing Quality oversight of clinical cell and gene therapy manufacturing. The individual will ensure cGMP compliance through production floor interactions, review and approval of batch records, and the investigation and closure of Quality events. The successful candidate will serve as a subject matter expert within QA and partner with cross-functional stakeholders to ensure project/program deliverables are completed according to ElevateBio’s policies and procedures with a high degree of quality.   

Here’s What You’ll Do (Commercial Readiness)

• Lead, facilitate, collaborate and track Quality workstream deliverables for Commercial Readiness project
• Author and review updates to Standard Operating Procedures, Policies, Risk Assessments, and other documentation in accordance with project schedule and plan.  
• Direct ownership of Quality Operations owned documentation and support/review of other functional documentation that is part of the project.
• Develop implementation plans and remediation plans as part of the implementation of new policies, procedures and programs. Support remediation of any gaps.
• Partner with CMC Regulatory and SMEs to assess compliance with regulatory guidelines and industry best practices for US and EU markets to ensure appropriate quality processes and procedures are implemented for commercial cell-therapy GMP manufacturing, at-scale and in-compliance.

Here’s What You’ll Do (Quality Operations)

• Ensure timely disposition of starting material, intermediates, drug substance and drug product.
• Serve as Quality point-of-contact for client programs.
• Provide on-the-floor QA oversight and support in the cleanroom suites to ensure compliance to cGMP regulations throughout the manufacturing process.
• Ensure all product-related deviations are initiated, investigated and resolved in a timely, compliant, and scientifically sound manner.
• Ensure that associated CAPAs are initiated and resolved.
• Perform review of Quality records including Batch Records, Test Records, GMP protocols/reports, lab investigations, work orders, and change controls.
• Identify compliance risks and escalate the issues to appropriate levels or management for timely resolution.
• Develop and coach team members for fostering a Quality Culture and enabling performance.

Requirements:

• Minimum Bachelor’s Degree in Engineering, Science, or related field.
• At least 8 years of experience in a Manufacturing, Technical Operations, Quality or GMP environment supporting complex products.  At least 5 years in a Quality Assurance role.  At least 3 years managing individuals or project teams.
• Experience in autologous/allogeneic cell therapies or gene therapies is a plus.
• Direct experience working in a commercial manufacturing facility strongly preferred.
• Experience and/or familiarity with regulatory guidelines (ex. FDA CFR, EU EudraLex/Annex) is a plus
• Demonstrated ability and strength in leading cross-functional teams within a matrixed organization.