The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. 


Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.


Leads the Quality Assurance team, including Quality Systems and Quality Operations. Responsible for raw material inspection and release, Quality on the floor, disposition of drug product/drug substance, QA review of quality control data, root cause analysis, risk management, technical writing, deviation, change and CAPA management, document/records management, quality metrics reporting, data integrity, training management, QA review of method qualification/validation, process qualification/validation, and equipment/utilities/ facilities qualification and continuous improvement.  Responsible for ensuring internal audits, client audits, supplier quality management, managing regulatory inspections, and quality systems are implemented effectively, efficiently, and compliantly at the site. Help build scalable, phase appropriate Quality systems as the organization continues to grow.


  • Act as a leader in the Quality organization, helping define and drive the Quality vision, mindset, and culture of the entire company in close collaboration with the Vice President of QA and Regulatory
  • Develop overall program, implementation, and continuous improvement of the Quality Systems, which encompass but not limited to: QMS (Deviation, Change Control, CAPA), Documentation, Training, Supplier Management, Internal/Customer Audits and Customer Complaints.
  • Ensure that Quality Systems are designed and operating in a way to provide appropriate support in all GxP areas of the company and are in compliance with current ISO and GMP standards (cGMP) both US FDA and EU applicable to gene therapy as appropriate for early phase clinical trials
  • Develop, implement, and maintain corporate policy and procedures for the Quality Management System in accordance with ICH Q10 model
  • Take lead role in evaluating continuous improvement options for the Quality Systems post initial implementation
  • Responsible for supporting all client projects as the quality lead and attending all meeting for current and prospective clients.
  • Develop user requirements and contribute to the configuration, validation, implementation, and lifecycle management of the electronic Quality Management System (eQMS - Veeva)
  • Develop, implement, and oversee a Quality Supplier Management Program that serves all GxP areas including introduction and qualification of suppliers and materials, supplier material changes, supplier complaints
  • Ensure that all products manufactured at the site are produced, tested, and released in compliance with SOPs, cGMP’s, US FDA, and EU requirements.
  • Establish and continuously improve the Incoming Quality Assurance (IQA), Quality Oversight, and Batch Release programs
  • Responsible for all raw material and final product release from the facility
  • Establish department / individual goals and key performance indicators in alignment with company and operational goals
  • Maintain and report applicable department and delivery metrics
  • Establish the Quality Management Review Program, including facilitating creation of the presentation materials to include the Key Performance indicators, the meeting agenda, and attendance, and to orchestrate the material presentation
  • Manage internal quality improvement initiatives: evaluate internal processes, suggest/design/implement improvements, create/revise relevant SOPs/Policies
  • Act as subject matter expert and provide training on all Quality Management Systems, including but not limited to change control, quality events, investigation, and implementation of effective CAPAs
  • Own and oversee the compilation of the Site Master File (SMF)
  • Coach, train, and develop the Quality team
  • Develop budget for department and ensure adherence to the budget
  • Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
  • Stay current with regulatory guidance as it applies to the Gene Therapy and early phase clinical trials
  • Act as a member of the site leadership team and engage in business decision-making from a Quality perspective
  • Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QA department


  • Adaptability required as work schedule may change based on business needs
  • Criminal background check and drug screen required
  • Other duties as assigned




BS degree in science or related field


In depth Knowledge in industries regulated in-part by, 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, Eudralex Volume 4, ICH Quality Guidelines, and Guidance to Industry dockets, as applicable for early phase clinical trials


Certified Auditor




10+ years of experience Quality Professional in Pharmaceutical and/ or Biological Manufacturing


7+ years of experience Quality Systems


5+ years of experience Quality Management


Experience conducting Supplier Audits, including for API


Experience with Phase I/II IND clinical trials




Manage multiple projects, set priorities, and work in fast-paced environment


Communicate confidently and effectively with management, peers, and key stakeholders


Demonstrate effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management, training, and problem solving


Demonstrated ability to develop quality systems and a quality management plan


While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

  • Occasionally exposed to loud noise levels
  • Position can be combination of remote and on-site
  • Regularly sit for long periods of time


  • Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
  • Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl


  • Frequently lift and/or move up to 10 pounds
  • Occasionally lift and/or move up to 25 pounds


  • Frequently utilize close vision and the ability to adjust focus


  • Frequently required to communicate by talking, hearing, using telephone and e-mail


Growth Mindset
Believe that skill is developed through dedication and hard work.
Intelligence & talent are just the starting point.
Mistakes are valuable lessons, not shameful indictments.

Adapt rapidly to a quickly changing, CDMO environment.
Respond by constructively creating & impacting opportunity through active participation.

Team Focus
Work together; succeed together; fail together.

Do the right thing, on time, every time.
Speak up when needed.
Exercise respect.

Embrace the unique viewpoint of each individual.
Join the ongoing journey to a more inclusive workplace and community where we all help each other get better.


  • Paid vacation days, amount based on tenure, and paid sick time
  • 9 observed holidays + 1 floating holiday + 1 volunteer day
  • 401(k) plan with company match up to 6% of salary, vested immediately
  • Choice of UHC healthcare plans
  • FSA and HSA programs
  • Dental & vision care
  • Employer-paid basic term life/personal accident insurance
  • Voluntary disability, universal life/personal accident insurance
  • Accidental Death & Dismemberment (AD&D) Insurance
  • Educational Assistance Program


  • Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
  • This position is located in Fishers, Indiana.
  • This position requires a criminal background check.
  • Genezen is an Equal Opportunity Employer.
  • Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen is located in Fishers, Indiana, a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.

Apply for this Job

* Required
resume chosen  
(File types: pdf, doc, docx, txt, rtf)
cover_letter chosen  
(File types: pdf, doc, docx, txt, rtf)
When autocomplete results are available use up and down arrows to review
+ Add another education

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Genezen’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Please reach out to our support team via our help center.
Please complete the reCAPTCHA above.