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Director of Quality Assurance

Indianapolis, IN

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. 

WORKING AT GENEZEN

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.

PURPOSE

Leads the Quality Operations team. 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, QA review of method qualification/validation, process qualification/validation, and equipment/utilities/ facilities qualification and continuous improvement.  Responsible for ensuring client audits, 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.

ESSENTIAL JOB FUNCTIONS / DUTIES

  • 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 Quality and Regulatory
  • Regulatory Compliance and Inspection Readiness: Serve as the quality lead in interactions with regulatory authority inspectorates (FDA, EMA, etc.) and other external auditors and ensure audit readiness to support both planned and unplanned inspections
  • Cross-Functional Collaboration: Work closely with Manufacturing, Supply Chain, Regulatory Affairs, Clinical Operations, Pharmacovigilance, Medical Affairs, and other key teams to embed quality into each phase of the development and commercialization process, ensuring all processes support consistent quality and compliance standards.
  • Represent Quality on all client projects, including attending meetings for current and prospective clients.
  • 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
  • Manage internal quality improvement initiatives: evaluate internal processes, suggest/design/implement improvements, create/revise relevant SOPs/Policies
  • Team Development and Leadership: Mentor and lead a high-performing QA team to ensure a culture of quality across the organization. Provide guidance, training, and development to keep the team up to date with evolving quality and regulatory standards.
  • 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

SPECIAL JOB REQUIREMENTS

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

KNOWLEDGE, SKILLS & EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

Bachelor’s degree in science or related field

Essential

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

Essential

Familiarity of eQMS systems such as Veeva

Desired

Knowledge of clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms

Desired

Knowledge of cGxPs, clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms

Desired

ON-THE-JOB EXPERIENCE

 

3-5 years of working experience in a Pharmaceutical or Biologics industry in a Quality Assurance role

Essential

Experience working in with early phase clinical trial production and testing

Desired

Previous experience with a startup CDMO and/or in the field of Gene Therapy

Desired

SKILLS / ABILITIES

 

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

Essential

5+ years of experience Quality Management

Essential

Experience working in with early phase clinical trial production and testing

Essential

Previous experience with a startup CDMO and/or in the field of Gene Therapy

Desired

Proven ability to work cross-functionally to achieve business outcomes

Desired

Leadership Abilities: Proven ability to lead and inspire a QA team, fostering a strong quality culture throughout an organization. Ability to work cross-functionally to drive quality initiatives in a collaborative, commercial-focused environment.

Essential

Analytical and Problem-Solving Skills: Strong skills in risk assessment, root cause analysis, and problem-solving, with experience managing complex quality issues in a high-paced, regulated environment.

Essential

Communication Skills: Excellent verbal and written communication skills, with a proven track record of engaging and influencing internal and external stakeholders, including regulatory agencies.

Essential

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

Essential

PHYSICAL DEMANDS
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

Movement

  • 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

Vision

  • Frequently utilize close vision and the ability to adjust focus

Communication

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

GENEZEN'S CURES VALUE-BASED COMPETENCIES

Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success. 

Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

  • Paid vacation days, amount based on tenure
  • Paid sick time
  • 10 observed holidays + 2 floating holiday + 1 volunteer day
  • 401(k) plan with company match up to 6% of salary, vested immediately
  • Share Appreciation Rights
  • Choice of several 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

ADDITIONAL DETAILS

  • 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 requires a criminal background check.
  • Genezen is an Equal Opportunity Employer.
  • Genezen participates in EVerify.
  • 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 has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. 

Fishers is 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.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

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This position requires a criminal background check and drug screening.

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.

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