Quality Systems Lead

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 Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY The Quality Systems Lead will be responsible for overseeing and enhancing our Quality Management System (QMS) with a focus on electronic QMS support, risk assessments, inspection readiness, and compliance activities. This role requires a proactive individual who can manage and improve quality systems, ensure regulatory compliance, and support cross-functional teams in achieving quality objectives. ESSENTIAL JOB FUNCTIONS / DUTIES QMS Support: Manage and configure the electronic QMS platform to ensure optimal functionality and alignment with organizational needs. Provide training to employees on the use of the electronic QMS system, ensuring they understand and adhere to its processes and features. Troubleshoot and resolve issues related to the electronic QMS, working closely with IT and system vendors as needed. Generate and analyze reports from the electronic QMS to monitor system performance and identify areas for improvement. Track and report on KPIs relative to the QMS. Facilitate the Change Control Review Board Meetings in accordance with internal procedures. Manage the Change Control process, ensuring that all changes to the QMS and related processes are properly documented, evaluated, and approved. Risk Assessments: Support the development and implementation of risk assessment methodologies and tools. Facilitate risk assessment activities and ensure risks are identified, evaluated, and mitigated effectively. Document and communicate risk assessment findings to relevant stakeholders. Inspection Readiness & Audit Support: Prepare for and support internal and external audits and inspections by performing walk throughs and supporting internal audits. Work with cross functional teams to develop action plans to address audit findings and non-conformities. Act as a primary point of contact for auditors, providing necessary documentation and information. Regulatory Compliance: Stay current with applicable regulations, guidelines, and industry standards (e.g., FDA, EMA, ICH) and ensure all Quality Systems are compliant. Prepare for and participate in regulatory inspections and audits. Continuous Improvement: 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 across the organization. SPECIAL JOB REQUIREMENTS Adaptability required as work schedule may change based on business needs Criminal background check and drug screen required Other duties as assigned KNOWLEDGE, SKILLS & EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES Essential/Desired Bachelor's degree in a related field (e.g., Quality, Engineering, Life Sciences) Essential Advanced Degree Desired Certified Quality Auditor (CQA) Desired ON-THE-JOB EXPERIENCE Minimum of 5 years of experience in Quality Assurance or Quality Systems within the pharmaceutical, biotechnology, or medical device industry. Essential Experience and aptitude for with Veeva and/or other eQMS software systems. Desired SKILLS / ABILITIES Demonstrated ability to manage projects effectively and deliver results within established timelines. Essential Proven experience in CAPA management, Change Control processes, and audit support. Desired Excellent problem-solving skills and the ability to work collaboratively across departments. Desired Strong communication skills, with the ability to train and support team members effectively. Essential PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment Regularly sit for long periods of time Movement Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms Occasionally required to walk, stoop or crouch Lifting Frequently lift and/or move up to 10 pounds. Rarely lift and/or move up to 25 pounds. Vision Frequently utilize close vision and the ability to adjust focus Communication Frequently required to communicate by talking, hearing, using telephone and e-mail GENEZEN'S CURES VALUE-BASED COMPETENCIES C ommitted to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. U rgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. R esilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. E xecute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. S olutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. GENEZEN'S BENEFITS Paid vacation days, amount based on tenure Paid sick time 9 observed holidays + 1 floating holiday + 1 volunteer day 401(k) plan with company match up to 6% of salary, vested immediately Share Appreciation Rights Choice of several healthcare plans FSA and HSA programs Dental & vision care Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance Accidental Death & Dismemberment (AD&D) Insurance ADDITIONAL DETAILS Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time. This position requires a criminal background check. Genezen is an Equal Opportunity Employer. Genezen participates in EVerify. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas. Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live. Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

Created: 2024-11-05