Director/Sr. Director, Quality Assurance Operations

Genezen; Lexington (MA); On-site; USD 170,000 - 240,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan

Healthcare plans

FSA/HSA programs

Life insurance

Disability insurance

Job summary

Genezen in Lexington, MA, seeks a Director/Sr. Director of Quality Assurance Operations to oversee the QMS and ensure cGMP compliance across facilities, manufacturing, QC labs, and the supply chain.

Ideal candidate has 10+ years of GMP experience, a Bachelor’s or Master’s in Life Sciences or Engineering, and a proven ability to lead, drive CAPA, audits, and regulatory readiness while liaising with senior management.

Qualifications

• 10+ years of GMP experience in pharma/biotech quality roles (description)
• Experience in a cGMP manufacturing environment
• Well versed in cGMP/ICH/FDA/EU regulations and guidelines
• Strong written and verbal communication with cross-functional teams
• Ability to work with minimal supervision

Responsibilities

• Develop, implement, and improve Quality Management Systems to ensure global regulatory compliance
• Provide guidance on phase-appropriate cGMP requirements
• Manage investigations and CAPA
• Review and disposition raw materials, intermediates, drug substance, and drug product
• Support Manufacturing, MSAT, FEV, Quality Control, and Supply Chain with QA
• Develop and report Quality System Metrics and risks to senior management
• Support internal and external audit programs
• Host and support inspections by health authorities
• Assess impact of new/regulatory changes on QMS and operations
• Maintain strong QA relationships with clients

Skills

Quality Assurance

GMP

cGMP manufacturing

Regulatory compliance

Quality systems

Documentation

Cross-functional collaboration

Education

Bachelor’s or Master’s Degree in Life Sciences or Engineering

Tools

MS Office

Job description

Director/Sr. Director, Quality Assurance Operations

Lexington, MA

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

Manypeople 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

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

Experience working in a cGMP manufacturing environment

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

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

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

Strong organizational skill

High level of attention to detail

Good problem-solving skills Essential

Capable of working with minimal supervision

Ability to work well with diverse groups

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

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:

• 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 toscientific 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
• 401(k) plan with company match up to 6% of salary
• Choice of several healthcare plans
• FSA and HSA programs
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident 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.

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.

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 hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential 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.

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 measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis 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.