Manager/Sr. Manager, Validation - CSV & Data Integrity

The posting, as Genezen wrote it

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 Manager/Sr. Manager, Validation - CSV & Data Integrity is responsible for ensuring that computerized systems supporting GxP operations are appropriately assessed, validated, implemented, controlled, and maintained throughout their lifecycle. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GxP software applications. Supports the Data Integrity program to ensure that GxP data is reliable, complete, accurate, attributable, secure, and maintained in accordance with regulatory expectations and company quality standards. Collaborates with cross functional teams, ensuring compliance with regulatory requirements, and drives best‑in‑class validation practices that support our Quality Management System and operational excellence.

JOB RESPONSIBILITIES

Computer Systems Validation

• Manage the organization's Computer Systems Validation (CSV) strategy, governance framework and establish risk-based approaches for validation of GxP computerized systems.
• Establish validation standards, templates, procedures, and best practices for the organization. Ensure validation strategies are aligned with business requirements, quality risk, regulatory expectations, and company policies and procedures.
• Provide CSV leadership for implementations, upgrades, patches, configuration changes, integrations/interfaces, data migrations, system replacements and retirement/decommissioning
• Ensure appropriate validation oversight throughout the computerized system lifecycle.
• Oversee development and execution of validation deliverables, including Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ Protocols, Test Plans/Scripts, Traceability Matrices, Validation Summary Reports, etc.
• Ensure computerized systems remain in a validated/compliant state and validation activities are appropriately planned, documented, reviewed, and approved before systems are released for GxP use.
• Manage multiple concurrent validation projects, priorities, risks, manpower, and dependencies.
• Manage and execute periodic reviews and validation status activities.

Data
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ve 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.