Lead, Quality Systems

Genezen•Lexington, MA

6d•$110,000 - $130,000

About The Position

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 administering 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.

Requirements

Bachelor’s degree in a related field (e.g., Quality, Engineering, Life Sciences) Essential
Minimum of 5 years of experience in Quality Assurance or Quality Systems within the pharmaceutical, biotechnology, or medical device industry. Essential
Demonstrated ability to manage projects effectively and deliver results within established timelines. Essential
Strong communication skills, with the ability to train and support team members effectively. Essential
Adaptability required as work schedule may change based on business needs
Criminal background check and drug screen required
Other duties as assigned

Nice To Haves

Advanced Degree Desired
ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality (CMQ), or equivalent. Desired
Experience and aptitude for with Veeva and/or other eQMS software systems. Desired
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

Responsibilities

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, ensuring they understand and adhere to its processes and features.
Troubleshoot and resolve issues related to the electronic QMS, working closely with IT, internal departments, 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.
Review QMS records, including Deviations, CAPA, Change Control, Effectiveness Checks, and Extension Requests, to ensure they are thorough, and adhere to established procedures.
Offer guidance and support to staff across the organization to improve robustness of QMS records.
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.
Engage in regulatory surveillance initiatives.
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.