Genezen

Viral-vector and cell-therapy CDMO provider

Director/Senior Director - Quality Assurance Operations

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeLexington, MA, USA$170k - $240k /yrIn-person

About the Job

Requirements

A Bachelor's degree and/or Master's degree in Life Sciences or Engineering is desired.
At least 10 years of relevant good manufacturing practice experience in the pharmaceutical or biotechnology industry in a Quality role is essential.
Experience working in a current good manufacturing practice manufacturing environment is essential.
Knowledge of current good manufacturing practice, International Council for Harmonisation, Food and Drug Administration, and European Union regulations and guidelines is essential.
Proficiency with Microsoft Outlook, Microsoft Teams, Microsoft Word, Microsoft Excel, and Microsoft PowerPoint is essential.
Strong written and verbal communication skills for interacting with cross-functional teams are essential.
Strong organizational skills are essential.
High attention to detail is essential.
Problem-solving skills are essential.
Ability to work with minimal supervision is essential.
Ability to work well with diverse groups is essential.
Ability to multitask in a fast-paced environment with challenging timelines is essential.
Adaptability is required because the work schedule may change based on business needs.
A criminal background check is required.
Ability to work frequently in a Biosafety Level 2 environment with personal protective equipment and aseptic gowning is required.
Ability to work around large machinery and typical utilities in pharmaceutical facilities is required.
Ability to spend time on the floor during maintenance, construction, commissioning, and qualification activities is required.
Ability to meet the physical demands of frequently standing and sitting, and occasionally walking, climbing or balancing, and stooping or crouching is required.
Ability to use close vision and adjust focus is required.
Ability to communicate frequently by speaking, hearing, telephone, and email is required.

Responsibilities

Oversee all elements of the Quality Management System to ensure processes adhere to global current good manufacturing practice regulations, including quality oversight of facilities, engineering, validation, manufacturing, quality control laboratories, supply chain, packaging and labeling, distribution, and external suppliers.
Build and motivate a high-performing Quality Assurance organization that supports compliance, accountability, efficient execution, collaboration, integrity, and delivery of gene therapy medicines.
Manage the development, implementation, maintenance, and improvement of relevant Quality Management Systems and processes to ensure regulatory compliance and alignment with company strategy.
Guide operations on phase-appropriate current good manufacturing practice requirements aligned with global regulations and internal Quality Management Systems.
Manage investigations and implement timely and effective corrective and preventive actions.
Manage the review and disposition of raw materials, intermediates, drug substance, and drug product, and ensure timely and accurate completion of reported quality events.
Provide Quality Assurance support to Manufacturing, Manufacturing Science and Technology, Facilities, Engineering and Validation, Quality Control, and Supply Chain operations.
Develop, implement, and improve Quality System metrics; report performance trends and risks to senior management.
Support a risk-based internal and external audit program.
Host and support management of pre-approval inspections and subsequent routine global health authority inspections.
Assess the impact of new or updated regulations on company Quality Management Systems and operations.
Develop and maintain a high-performing Quality Assurance organization to execute organizational responsibilities effectively.
Manage and maintain strong Quality-to-Quality relationships with clients.
Perform other duties as assigned.

Desired Qualifications

A Bachelor's degree and/or Master's degree in Life Sciences or Engineering.

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, Quality 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

COMPENSATION RANGE:

The anticipated annual salary range for the Director/Sr. Director is$170,000-$240,000. Salary determined based on relevant experience, skills and education.

PHYSICAL DEMANDS

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

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

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
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.

About the Company

Genezen

Viral-vector and cell-therapy CDMO provider

Genezen is a contract development and manufacturing organization (CDMO) focused on gene and cell therapies, specializing in viral vectors and transduced cells. It provides end-to-end, fee-for-service development and cGMP manufacturing, from early development through clinical-grade vector production for trials. The company differentiates itself by offering a global, single-partner solution that covers the entire viral vector and cell-therapy pipeline. Its goal is to help clients advance gene and cell therapy programs by delivering reliable development, manufacturing, and testing support toward clinical trials.

Company size: 201-500
Company stage: Growth Equity (Venture Capital)
Total funding: $18.5M
Headquarters: Lexington, MA
Founded: 2014

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