Senior Specialist Quality Systems

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization.Located in Columbus, OH , the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities. Our Values are founded in our origin story. The name “Andelyn” is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible. Through this journey, we have been able to acceleratethedevelopment and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality™ through our ACCTS ions. A CCOUNTABLE in our actions. C OMPASSIONATE in our thinking. T RUSTWORTHY in our communications. S UPPORTIVE of one another. Employees are expected to perform the following essential functions under the framework of our ACCTS ions. The Senior Specialist, Quality Systems is an individual contributor role within the Quality organization responsible for supporting the oversight, effectiveness, and continuous improvement of the Quality Management System (QMS) for a GMP clinical and commercial manufacturing facility. The role partners cross-functionally to maintain a compliant, efficient, scalable, and inspection ready Quality System that supports site operations, product lifecycle activities, and organizational priorities. This position will lead and support strategic Quality Systems initiatives, including QMS process improvements, metrics and trending, risk management, management review, audit and inspection readiness, and QMS system deployment or enhancement activities. The Senior Specialist, Quality Systems will also support change control assessments, as applicable, by coordinating Quality System documentation, assessing process impacts, and supporting compliance related activities. Support key QMS processes, including change control, risk management, Quality Management Review, deviations, CAPAs, and related Quality System activities. Lead and support cross-functional Quality Systems and continuous improvement initiatives to address compliance risks, process gaps, inefficiencies, and evolving business needs. Develop and maintain QMS procedures, workflows, templates, tools, trackers, and governance processes to improve consistency, usability, and compliance. Compile, analyze, trend, and communicate Quality metrics and key performance indicators to identify emerging risks, recurring issues, and opportunities for improvement. Support Quality Management Review activities, including preparation of metrics, trend reports, risk information, presentations, action tracking, and follow-up. Support the site risk management program, including maintenance of the site risk register and facilitation of risk assessments, as needed. Lead or support strategic Quality initiatives, including process harmonization, inspection readiness activities, implementation of new GMP expectations, and compliance related improvement projects. Support Quality Management System deployment, system upgrades, enhancements, integrations, and other optimization initiatives, including business-process mapping, requirements gathering, testing, training, implementation, and post-deployment follow-up. Partner with Quality, Manufacturing, Technical Operations, Information Technology, Supply Chain, and other functions to ensure effective implementation and ongoing use of Quality Systems and related tools. Support internal, customer, and regulatory audits and inspections, including readiness activities, document and evidence coordination, response support, action-plan tracking, and closure activities. Help support change control assessments, as applicable, through coordination of Quality documentation, assessment of QMS impacts, and support for compliance-related deliverables. Provide Quality Systems guidance, training, and support to internal stakeholders. Support deviations, investigations, OOS activities, and CAPAs, as needed; this may include review, tracking, trending, and effectiveness activities. Perform other duties as assigned. . What you bring to the team. Bachelor’s degree in Life Sciences, Engineering, or a related discipline required. Minimum of 8 years of experience in a GMP regulated pharmaceutical, biotechnology, biologics, gene therapy, or related life sciences environment required. Minimum of 3–5 years of direct experience in Quality Assurance, Quality Systems, Quality Compliance, or a related Quality function required. Experience supporting both clinical and commercial GMP manufacturing operations required. Experience supporting internal audits, customer audits, and/or regulatory inspections required. Experience with aseptic manufacturing operations strongly preferred. Strong knowledge of cGMP regulations and guidelines, including applicable requirements under 21 CFR Parts 11, 210, and 211; ICH guidelines; relevant European requirements; and other applicable GMP expectations. Demonstrated experience with QMS processes, Quality Systems governance, quality metrics, trend analysis, risk management, and continuous-improvement activities. Strong project management, organization, communication, and problem-solving skills, with the ability to manage multiple priorities and adjust as business needs change. Strong written communication and technical documentation skills. Advanced proficiency in Microsoft Office applications, including Excel, PowerPoint, and Word, with the ability to analyze, interpret, and present data effectively. Ability to work independently and collaboratively in a diverse, inclusive, and cross-functional work environment. Demonstrated ability to handle confidential information appropriately and maintain discretion. Client-focused mindset and strong internal customer-service orientation. What you can expect when working at Andelyn. The pride of contributing to the development and manufacturing of life-saving therapies The invaluable experience of being a part of building the foundation of a new organization. The opportunity to work alongside experts who have over 10 years in the gene therapy field. Competitive compensation Eligible day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid 160 hours of Paid Time Off annually 11 Company Paid Holidays plus 2 floating holidays annually. Company Paid Life Insurance 401(k) Match Company Paid short and long-term disability. 4 weeks of Paid Parental Leave for birth and adoption Adoption Assistance Tuition Reimbursement and Student Loan Repayment Assistance Company Paid LinkedIn Learning access. Employee Assistance Programs Flexible work options (role specific) Andelyn Biosciences embraces diversity and is an equal opportunity employerand does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status. As an organization, we are committed to creating an environment where everyone ACCTS. We invite you to complete the optional self-identification questions below used for compliance with government regulations and record-keeping guidelines. Any self-identification information provided will not be considered in the selection process. We are required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at #J-18808-Ljbffr Andelyn Biosciences, Inc.