Regenxbio2mo ago

Director/Senior Director, GCP & GLP QA (Hybrid)

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Quick Summary

Overview

Who we are REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science,

Technical Tools

excelgcpproject-management

Who we are

REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.

The opportunity

The (Sr.) Director, GCP & GLP QA will ensure robust quality assurance systems and procedures are in place to cover REGENXBIO’s pre-clinical activities through clinical trial operations. You will also ensure non-clinical and clinical study execution are compliant with applicable GLP, GCLP, and GCP regulatory requirement as well as regulatory compliance of both internal functions and outsourced activities through oversight of audit activities, utilizing internal and external resources. You will have the opportunity to interface and collaborate with representatives from Clinical Operations, Biometrics, Clinical Development, Regulatory Affairs, Bioanalytical and Preclinical functions.

Develops/improves quality programs and procedures to promote, facilitate, and ensure compliance with domestic and international regulatory and industry standards and implement risk-based methodologies to improve efficiencies

Authors and/or reviews and approves Standard Operating Procedures (SOPs)

Reviews/approves or audits clinical and regulatory documentation and other clinical data to ensure accuracy and data integrity for GCP, GLP and GCLP activities as required

Evaluates internal systems and external clinical sites and vendors to determine acceptable compliance to applicable regulations and guidelines. Includes but is not limited to: Clinical Investigator Sites, External CROs/Vendors, Laboratories (clinical and non-clinical), and Trial Master Files

Provides QA support for risk assessment and remediation, and identification and investigation/CAPA of Critical Quality Issues as needed

Oversees/approves non-clinical and clinical supplier and site audit/assessment schedules and facilitates the selection of contract auditors to support the clinical auditor program, as required and per defined budget

Participates in or leads internal and vendor audits to ensure patient safety and data integrity

Oversees clinical quality event and CAPA process

Develops and delivers training on good clinical practice concepts and specific GCP procedures

Represents QA at internal clinical and GCLP team meetings

Supports key quality processes, metrics and indicators to measure trends and improve key quality determinants of GCP and supporting GxP operations

Effectively communicates progress and issue resolution to appropriate internal/external stakeholders

Stays up-to-date with current regulatory changes and industry trends and translates new requirements back to the company’s policies and procedures

Facilitate/lead QA activities for GLP/GCP regulatory inspection management

Promotes a culture of quality and operational excellence through leadership of clinical quality function and partnering with other departments throughout the organization

Plans, resources, and manages staff to ensure efficient operations and encourage development of capabilities

Must be able to travel up to 10-20% of time

BS, preferably in a biological science

Must have direct job experience in a Clinical QA or GLP QA role

Extensive experience conducting and overseeing audits

Extensive knowledge of FDA and EU regulations as well as ICH guidelines

Minimum of 10 years of experience in a Quality Assurance/Quality Systems/Clinical QA position in biopharma / biologics / cellular therapy / gene therapy in a regulated environment

Excellent interpersonal skills and ability to effectively interact with and influence different functional groups at multiple levels of the company

Ability to interpret regulations and practically apply them to procedures

Excellent oral and written communication skills for effectively interfacing with internal and external organizations

Strong project management skills

Ability to manage multiple priorities with aggressive timelines and changing priorities

Must have excellent attention to detail

Possesses strong critical and logical thinking

Basic proficiency in MS PowerPoint, Excel and Word

Location & Eligibility

Where is the job

Worldwide

Fully remote, anywhere in the world

Who can apply

Same as job location

Listed under

Worldwide

Listing Details

Posted: February 27, 2026
First seen: March 26, 2026
Last seen: May 6, 2026

Posting Health

Days active: 41
Repost count: 0
Trust Level: 32%
Scored at: May 6, 2026

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Regenxbio

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REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy, utilizing its proprietary NAV® Technology Platform to develop a pipeline of AAV therapeutics for retinal, metabolic, and neurodegenerative diseases.

Employees

350

Founded

2009

Domain

Jobs

External application · ~5 min on Regenxbio's site

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