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 accelerate thedevelopmentand manufacturing of innovative therapies to bring more treatments to more patients. We are Pioneering Solutions that Turn Hope into Reality through our ACCTSions.

ACCOUNTABLE 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.

What you will do.

• Support the various elements of the QMS, including but not limited to;
  Deviations, CAPAs, Change Controls, Risk Management, Quality Management Review, and Validation activities.
• Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaboration with internal stakeholders to support the effective execution of the Investigation and CAPA systems.
• Supporting discussing, clarify, define and manage approaches on the investigation process on the deviations and CAPA's with the clients maintain and open communication.
• Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, Out-of-Specification and CAPA processes
• Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations
• Provides technical assistance and training for personnel
• Report out of Quality metrics to internal and external stakeholders.
• Maintain a site risk register while supporting the Risk Management program
• Support internal and external audits and inspections.
• Files and maintains controlled documents
• Other duties as assigned.

What you bring to the team.

• Minimum Bachelor’s degree in Life Sciences, Engineering, or related field.
• Preferred:
  Minimum of 8 years of experience in Quality, or a related field in a GMP environment.
• Experience in biologics or gene therapy required
• Experience in highly regulated field preferred
• Proficient knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211, European Directives, ICH guidelines, and cGMP regulations
• Experience in commercial and clinical GMP production and ability to provide QA support for both
• Experience with aseptic manufacturing operations required.
• Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
• Must be highly skilled in Microsoft…