Senior Specialist, Quality Systems

Overview

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 accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality™ through our ACCTSions.

ACCT
AINTOABLE in our actions.

COMPASSIONATE in our thinking.

TRUSTWORTHY in our communications.

SUPPORTIVE of one another.

Employees are expected to perform the following essential functions under the framework of our ACCTSions.

The Senior Specialist, Quality Systems is an individual contributor role and provides compliance and quality assurance support to all the requirements for the core of the QMS process on the Andelyn organization which supports clinical and commercial GMP production. This position will report to the Quality Manager/Associate Director and will work closely with all the areas of the site operations (Business, M&ST, Validation, Engineering, Quality Control, Quality Assurance, Supply Chain, etc.)

and they will ensure compliance to defined Quality System procedures, manage the compliance on the change management process and standards and conduct moderate to high level information analysis. This position will also work collaboratively with the training team to ensure all the areas comply and quality systems. In addition, this position will interact with the different clients in the Change control process.

• Operate within the Quality Management System applicable to the manufacture of phase appropriate material GMP operations.
• Works closely with Operations colleagues of all the areas that required the support of the change management group to ensure control of clinical and commercial manufacturing. Track change controls within the Trackwise system to assure the proper implementation and adequate change management process.
• Responsible for the Change Control Review Board email distribution list and ensuring that it is kept current and updated, as needed
• Manage the multiple meetings to coordinate the proper implementation of the change controls and the change management methodology
• Act as the main point of contact for Change Controls and provide support to owners and approvers assigned in Trackwise
• Assist in the development of action plans and metrics to monitor Change Management within the Andelyn QMS
• Act as the owner of the Change Management SOP. Revise, as needed to ensure compliance with regulations and the Andelyn QMS
• Track Quality Technical Agreements to ensure reviews are performed following applicable SOPs, and compliance with the requirements of the change control process (Change management approach)
• Additional tasks within QA, as assigned.
• Operates in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved.
• Solving, correcting, preventing problems, and performing tasks as assigned by leadership, as well as assigning tasks to junior staff
• Work to specific measurable objectives requiring operational planning skills with little direct supervision
• Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contributes to the success…