Quality Assurance Supervisor

It’s an exciting time to join us!

The Andelyn Biosciences’ Quality Assurance group is seeking a motivated individual to join our growing team as a QA Supervisor in our QA Compliance Group.

The QA Supervisor ensures overall compliance with regulatory requirements, and company policies and procedures. The incumbent will assist in regulatory filings and participate in regulatory/client audits.  He/she will also oversee supplier quality, document management, Change Management, and overall Quality Management Systems.  He /She will cross-train with other areas of Quality Assurance

 

Schedule: Full-time (Benefits Eligible)  

Location:  Central Campus 

                       575 Children's Crossroads

                       Columbus, OH 43205 

 

Under the guidance and direction of the QA Compliance Manager, essential functions of the QA Supervisor include at a minimum:

·        Ensures the QMS system is compliant with regulations.

·        Utilizes electronic quality management systems to increase compliance, tracking, trending, and resolution of issues.

·        Implements internal and external audit program

·        Oversee the regulatory audits including, but not limited to, FDA, EMA, and other applicable health agencies.

·        Manages, Change Controls, Documents Control Quality Metrics, and supplier quality

·        Supports quarterly management review (QMR)

·        Defines, implements, and manages the inspection readiness program.

·        Champions the Quality risk management program

·        Manages Quality Metrics

·        Cross-trains with the Supervisor of QA operations and Supervisor of Investigations and CAPAs  

·        Reviews and approves change controls and other GMP documents as appropriate

·        Manages Suppliers and Vendor's Audit Program

·        Demonstrates a high level of integrity

·        Maintain a positive attitude

·        Works towards specific measurable objectives requiring operational planning skills with little direct supervision

·        Cultivate a collaborative team environment.

·        Utilizes clear and concise communication to ensure high productivity.

·        Responsible for hiring, development, mentoring, and supervision of personnel

·        Ability to manage and influence people in the direct and lateral support structure

·        Exercises broad decision-making within their functional units

·        Develops and drives timelines

·        Collaborates with Regulatory Affairs group as needed

·        Develops and monitors goals for subordinates

·        Interprets Regulations and Guidance documents, and implements them in the company

·        Has business acumen

·        Other duties as assigned

  

Knowledge, Skills, and Abilities required:

·        Must possess a bachelor, master's, or Ph.D. degree in biology, biochemistry, biotechnology, chemistry, or a relevant field

·        Background in the life sciences, biotechnology, or gene therapy is highly desirable

·        At least four years of experience in cGMP relative to biological products and cell cultures.

·        Broad knowledge of the field with demonstrated leadership skills

·        Prior supervisory experience is required

·        Excellent communication (oral and written), organizational, and project management, and multitasking skills

·        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

 

 

Minimum Physical Requirements

·        Frequently sitting/remaining in a seated position

·        Occasionally standing or walking

·        Occasionally independently lifting up to 50 pounds

·        Frequently talking on the phone or in-person

·        Frequently keyboarding

 

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification.  It is not to be construed as an exhaustive list of duties performed by the individual so find, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.    

 

Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

 

Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law.  As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to the first date of employment.  Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.