Senior Specialist, Quality Systems

Andelyn Biosciences, Inc • Columbus, OH

1d

About The Position

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. The Senior Specialist, Quality Systems is an individual contributor role and provides compliance and quality assurance support to the Clinical Manufacturing Facility (CMF). In this role, you will be part of the Quality Assurance team and report to the Associate Director, Quality Systems, responsible for maintaining various aspects of the Quality System, including deviation, CAPA, change control, validation, and risk management. This position will also work collaboratively with the Training Team to ensure manufacturing colleagues comply with Quality Systems.

Requirements

• Minimum Bachelor’s degree in Life Sciences, Engineering, or related field.
• 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 Office (PowerPoint, Excel, Word) including data interpretation and reporting.
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
• Must possess a client-focused mindset in daily tasks.
• Must possess prior experience handling confidential information and the ability to maintain confidentiality.

Nice To Haves

• Minimum of 8 years of experience in Quality, or a related field in a GMP environment.

Responsibilities

• 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.

Benefits

• 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 Paid Holidays plus 2 floating holidays annually.
• Company-paid 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior