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

Genezen•Lexington, MA

21d•$130,000 - $170,000

About The Position

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.

Requirements

Bachelor’s degree in Engineering, Computer Science or related discipline.
10+ years of Computer System Validation experience
Strong understanding and hands on CSV experience in implementations, upgrades, patches, configuration changes, integrations/interfaces, data migrations, system replacements and retirement/decommissioning projects
Collaborate and build strong partnerships across QA, QC, Manufacturing, Engineering, IT, Operations, and business functions.
Ability to communicate effectively and collaboratively with employees of all experience levels from Genezen, with project team members and other contract firms
Excellent communication skills (interpersonal, presentation, verbal and written)
Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
Excellent technical writing skills
Demonstrates good analytical problem-solving skills
Excellent project management skills
Strong working knowledge in Microsoft Office (Word, Excel, Visio, etc.) and Adobe Acrobat
Strong working knowledge of GxP regulations including 21 CFR Parts 11, 210/211, EU GMP Annex 11, data integrity guidances, ICH guidelines, and GAMP 5 best practices with the ability to assess compliance risks

Nice To Haves

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

Responsibilities

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.
Support the establishment of controls to protect GxP data throughout its lifecycle.
Support and continuously improve the organization's GxP Data Integrity program.
Serve as a subject-matter expert for ALCOA+ and data lifecycle management.
Establish risk-based approaches for identifying, assessing, and mitigating data integrity risks.
Ensure audit trail functionality and review processes are appropriately assessed during validation.
Support the risk-based audit trail review program.
Support data integrity assessments, user access reviews and audit trail reviews across GxP systems, processes, equipment, and laboratory/manufacturing environments.
Partner with QA, IT and business process owners to mitigate and address identified data integrity vulnerabilities.
Provide leadership and mentoring to CSV professionals, consultants, and cross-functional project teams.
Promote a strong culture of data ownership, accountability, and integrity.
Establish and monitor CSV KPIs, quality metrics and management reporting.
Monitor regulatory and industry trends ensuring the CSV program aligns with applicable regulatory requirements and industry expectations.
Provide leadership and ensure CSV aspects of deviations, investigations, CAPAs, and change controls are appropriately addressed.
Provide CSV SME leadership during audits and regulatory inspections and ensure remediation of CSV audit observations.