Genezen
Overview
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. WORKING AT GENEZEN Genezen aims to empower its employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of a fast-growing company. We strive to be a rewarding place to work where every employee contributes to the company’s success. Job Responsibilities
Essential job functions / duties QMS Support Design and Manage system QMS workflows to ensure optimal functionality and alignment with organizational needs. Provide training and coaching to employees on the use of the electronic QMS system. Troubleshoot and resolve issues related to the electronic QMS, coordinating with IT, internal departments, and vendors as needed. Generate and analyze reports from the electronic QMS to monitor performance and identify improvements. Track and report on KPIs related to the QMS. Facilitate the Change Control Review Board Meetings and manage the Change Control process. Review QMS records (Deviations, CAPA, Change Control, Effectiveness Checks, Extension Requests) for thoroughness and procedures compliance. Provide guidance to staff to improve robustness of QMS records. Support risk assessment methodologies and tools; facilitate risk assessment activities and communicate findings to stakeholders. Inspection Readiness & Audit Support Prepare for and support internal and external audits and inspections, perform walk-throughs, and assist with internal audits. Work with cross-functional teams to develop action plans to address audit findings and non-conformities. Serve as a primary point of contact for auditors, providing necessary documentation and information. Regulatory Compliance Stay current with applicable regulations, guidelines, and industry standards (FDA, EMA, ICH) and ensure QMS compliance. Engage in regulatory surveillance initiatives; prepare for and participate in regulatory inspections and audits. Own continuous improvement initiatives within the Quality Systems function to enhance efficiency, effectiveness, and compliance. Support cross-functional teams in identifying and implementing process improvements. Qualifications
Education / Certifications / Licenses Bachelor’s degree in a related field (e.g., Quality, Engineering, Life Sciences) Advanced Degree ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality (CMQ), or equivalent. On-the-Job Experience Minimum of 5 years of experience in Quality Assurance or Quality Systems within the pharmaceutical, biotechnology, or medical device industry. Experience with Veeva and/or other eQMS software systems. Skills / Abilities Proven ability to manage projects effectively and deliver results within established timelines. Experience in CAPA management, Change Control processes, and audit support. Excellent problem-solving skills and the ability to work collaboratively across departments. Strong communication skills for training and supporting team members. Compensation & Benefits
Pay Range : The annual salary range for this position is $110,000-$130,000. Paid vacation days, amount based on tenure 401(k) plan with company match up to 6% of salary (vested immediately) Choice of several healthcare plans FSA and HSA programs Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance Additional Details
Genezen is an Equal Opportunity Employer. We participate in EVerify. This position requires a criminal background check and drug screening. Genezen is not able to sponsor visas. Genezen operates two locations: Fishers, Indiana and Lexington, Massachusetts.
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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. WORKING AT GENEZEN Genezen aims to empower its employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of a fast-growing company. We strive to be a rewarding place to work where every employee contributes to the company’s success. Job Responsibilities
Essential job functions / duties QMS Support Design and Manage system QMS workflows to ensure optimal functionality and alignment with organizational needs. Provide training and coaching to employees on the use of the electronic QMS system. Troubleshoot and resolve issues related to the electronic QMS, coordinating with IT, internal departments, and vendors as needed. Generate and analyze reports from the electronic QMS to monitor performance and identify improvements. Track and report on KPIs related to the QMS. Facilitate the Change Control Review Board Meetings and manage the Change Control process. Review QMS records (Deviations, CAPA, Change Control, Effectiveness Checks, Extension Requests) for thoroughness and procedures compliance. Provide guidance to staff to improve robustness of QMS records. Support risk assessment methodologies and tools; facilitate risk assessment activities and communicate findings to stakeholders. Inspection Readiness & Audit Support Prepare for and support internal and external audits and inspections, perform walk-throughs, and assist with internal audits. Work with cross-functional teams to develop action plans to address audit findings and non-conformities. Serve as a primary point of contact for auditors, providing necessary documentation and information. Regulatory Compliance Stay current with applicable regulations, guidelines, and industry standards (FDA, EMA, ICH) and ensure QMS compliance. Engage in regulatory surveillance initiatives; prepare for and participate in regulatory inspections and audits. Own continuous improvement initiatives within the Quality Systems function to enhance efficiency, effectiveness, and compliance. Support cross-functional teams in identifying and implementing process improvements. Qualifications
Education / Certifications / Licenses Bachelor’s degree in a related field (e.g., Quality, Engineering, Life Sciences) Advanced Degree ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality (CMQ), or equivalent. On-the-Job Experience Minimum of 5 years of experience in Quality Assurance or Quality Systems within the pharmaceutical, biotechnology, or medical device industry. Experience with Veeva and/or other eQMS software systems. Skills / Abilities Proven ability to manage projects effectively and deliver results within established timelines. Experience in CAPA management, Change Control processes, and audit support. Excellent problem-solving skills and the ability to work collaboratively across departments. Strong communication skills for training and supporting team members. Compensation & Benefits
Pay Range : The annual salary range for this position is $110,000-$130,000. Paid vacation days, amount based on tenure 401(k) plan with company match up to 6% of salary (vested immediately) Choice of several healthcare plans FSA and HSA programs Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance Additional Details
Genezen is an Equal Opportunity Employer. We participate in EVerify. This position requires a criminal background check and drug screening. Genezen is not able to sponsor visas. Genezen operates two locations: Fishers, Indiana and Lexington, Massachusetts.
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