Sr. Associate, Quality Operations

About Genezen

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Be an integral part of the quality assurance and quality systems team by providing quality oversight and expertise to operations, manufacturing, and quality control activities. Address terms of product quality and conformance to regulations and Genezen quality policies/procedures. Help in the development of QA people and teams.

• Responsible for Quality Oversight of Manufacturing, Quality Control, and other areas as appropriate, through on the floor presence. Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements
• Provide guidance to production employees with the intent to foster understanding and compliance with SOPs, GMPs and process improvements.
• Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks
• Responsible for ensuring the Genezen documentation is compliant with cGMPs, GDPs, and consistent with other Genezen policies and procedures.
• Develop and optimize SOPs and other controlled documents for the Quality Assurance department.
• Review and approve SOPs and other controlled documents for the functional areas as the Quality representative.
• Review, approve and release critical raw materials for use in production and the quality control laboratories according to established specifications.
• Ensure that all products manufactured at the site are produced, tested and released in compliance with SOP’s, cGMP’s, FDA and EU requirements.
• Review, assess, and release quality control tests and Certificates of Analysis
• Review and approve Master Batch Records (M ’s) and executed batch records. Provide guidance and support to departments on errors to ensure error reduction.
• Assist in the final disposition of master cell banks and viral vector products.
• Provides site GMP and GDP training (annually, for new hires, and as needed).
• Initiate and perform Root Cause Analysis for Quality Events such as minor and major Deviations and Environmental Excursions. This includes gathering data from various sources across the site (ex. Quality oversight, trend data, and training records), as well as performing interviews of personnel related to the Quality Events.
• Working cross-functionally with all departments to ensure Quality Events are thorough and accurate.
• Drive Quality Events to closure within on-time closure deadlines.
• Review and approve, and implement (as applicable) specifications for labels for media fills, master cell banks and viral vector products
• Generate, review and approve Media Fill Protocols and summary reports, as well as participate as a Quality observer as needed.
• Perform and assist with Quality Oversight for Manufacturing, QC and warehouse.
• Review and approve Stability Protocols.
• Initiate, review, and approve Corrective and Preventative Actions (CAPAs) and monitor CAPA effectiveness with collaboration from Operational areas.
• Initiate, review, approve and monitor Change Management activities
• Work with the other functional areas to give guidance on use of quality systems.
• Lead and perform site internal audits.
• Lead and/or support customer audits, audit readiness and regulatory inspections by participating in either front or back room.
• Collaborate cross-functionally (e.g., Operations, Manufacturing, Regulatory, QC, other QA areas) to ensure product is manufactured according to approved procedures and complies with applicable regulations

• Adaptability required as work schedule may change based on business needs
• Criminal background check and drug screen required
• Other duties as assigned

• Bachelor’s degree in science or related field

• Experience in industries regulated in-part by 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, Eudralex…