Director/Sr. Director, Quality Assurance Operations

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.

JOB SUMMARY

The Director of Quality Assurance is responsible for oversight all elements of the Quality Management System (QMS), ensuring processes adhere to global cGMP regulations.  This includes quality oversight of all GMP functions including but not limited to Facilities, Engineering, Validation, Manufacturing, Quality Control Laboratories, Supply Chain, Packaging and Labeling, Distribution, and external Suppliers.

The Director of Quality Assurance is responsible for building and motivating a high performance and innovative Quality Assurance organization which enables a culture of compliance, trust and accountability, efficient execution, collaboration for success, and integrity and respect in order to deliver transformative gene therapy medicines.

ESSENTIAL JOB FUNCTIONS

Manages development, implementation, maintenance, and improvement of all relevant Quality Management Systems and processes to ensure compliance in line with global regulations and in alignment with the company’s strategy.

Provides guidance to operations on phase appropriate cGMP requirements aligned with global regulations and internal Quality Management Systems.

Manages investigations and implements timely and effective CAPA.

Manages the review and disposition of raw materials, intermediates, drug substance

, and drug product and ensures timely and accurate completions of reported quality events.

Provides Quality Assurance support to the following operation areas: Manufacturing, MSAT, FEV, Q uality Control, Supply Chain.

Responsible for developing, implementing and improving Quality System Metrics and for reporting performance trends and risks to senior management.

Supports a risk based internal and external audit program.

Responsible for hosting and supporting the management of PAI and all subsequent routine global health authority inspections.

Responsible for assessing the impact of any new or updated regulations on the company’s Quality Management Systems and operations.

Responsible for developing and maintaining a high-performing Quality Assurance organization to effectively execute organizational responsibilities.

Responsible for managing and maintaining strong

Quality to Quality relationships with clients.

SPECIAL JOB REQUIREMENTS

Adaptability required as work schedule may change based on business needs.

Criminal background check required.

• Other duties as assigned
• KNOWLEDGE, SKILLS AND EXPERIENCE
• Bachelor’s Degree and/or
• Master’s Degree in Life Sciences or Engineering

Desired

10+ years of relevant GMP experience in the pharma/biotech industry in a Quality role

Essential

Experience working in a cGMP manufacturing environment

Essential

Well versed in cGMP/ICH/FDA/EU regulations and guidelines

Essential

Proficient in using Microsoft applications (MS Outlook, MS Teams, MS Word, MS Excel, MS PowerPoint ect.)

Essential

Strong written and verbal communication skills to interact with cross function teams

Essential

Strong organizational skill

Essential

High level of attention to detail

Essential

Good problem-solving skills

Essential

Capable of working with minimal supervision

Essential

Ability to work well with diverse groups

Essential

Ability to multi-task in a fast-paced environment with challenging timelines

Essential

Work Environment:

Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.

Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.

Occasionally exposed to moving mechanical parts; caustic chemicals; hazardous waste.

Occasionally exposed to loud noise levels

Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required.

Movement:

Frequently required to stand; sit.

Occasionally required to walk; climb or balance; and stoop/crouch.

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

C ommitted to Science

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

U rgency in action for the patients

We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

R esilience & Grit in operations

We are committed to overcoming challenges, learning from failures, and persistently striving for success.

E xecute with Excellence & Integrity

We are dedicated to delivering quality results and upholding ethical principals.

S olutions 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
• 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 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.