Senior Specialist Quality Systems
Listed on 2026-10-05
-
Quality Assurance - QA/QC
Data Analyst -
Healthcare
Data Scientist
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
OM PASSIONATE in our thinking.
T
RUST WORTHY 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.
Thisposition 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…
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