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
As the Quality Assurance Compliance Specialist, you will audit and maintain GXP quality systems to support development phase gene therapy operations. You will support the internal and external audit programs to ensure Quality standards and business expectations are met. Additionally, you will work directly with external partners and internal resources to assure compliance with GXP regulations and continuous improvement of Quality Systems.
What you’ll be doing
Support implementation and routine management of core Quality Systems
Interpret regulations and guidance documents and apply to practical situations.
Provide QA support for raw material item approval, receipt and test specifications.
Maintain approved supplier list and supplier records.
Conduct and participate in scheduled audits of suppliers.
Manage supplier audit schedules, communicate with suppliers as needed to ensure audit CAPA completion and audit close-out.
Generate, review, and implement procedures as needed.
Track and trend supplier changes and performance
Perform quality transactions in inventory management systems for GXP materials.
Support GMP readiness activities for the new manufacturing facility, laboratories, and support areas
Provide QA support for risk identification, assessment, and remediation.
Review change controls, complaints, and investigations, demonstrating scientifically sound and compliant resolution.
Serve as the QA representative on cross-functional project teams.
Promote a culture of quality and operational excellence. Proactively identify areas for improvement and work across the organization to influence and implement solutions.
Interpret regulations and guidance documents and apply to practical situations.
Independently plan and perform assigned responsibilities and projects with minimal supervision.
It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships, and using clear communication to meet shared objectives.
We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:
BS degree in relevant scientific discipline with minimum of 5+ years relevant industry experience, 4+ years in QA or a related discipline
Working knowledge of relevant GXP regulations and supporting guidelines
Experience in GMP record review, investigations, change control, validation, and risk assessment.
Demonstrate a deep understanding of biologics manufacturing – process, analytical, operations, quality systems, regulations.
Ability to communicate clearly, both written and oral.
Strong organizational skills.
Ability to build strong collaborative relationships with partners in and outside the organization.
Working knowledge of FDA and EU GMP regulations as well as ICH guidelines
Experience using electronic quality systems to monitor, report, and track quality tasks and key quality performance indicators.
Proficient use of MS PowerPoint, Excel, and Word
Excellent communication and interpersonal skills for effectively interfacing with internal and external personnel at all levels.
Excellent attention to detail
Ability to manage and prioritize workload to meet aggressive timelines and changing priorities.
Experience performing Quality audits preferred.
Why should you apply?
By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.
We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!
In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.
Internal Number: QACOM01483
About REGENXBIO
REGENXBIO is a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno?associated virus (AAV) gene therapy. REGENXBIO's NAV® Technology Platform, a proprietary AAV gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO's mission is to transform the lives of patients suffering from severe diseases with significant unmet medical need by developing and commercializing in vivo gene therapy products based on REGENXBIO's NAV Technology Platform. REGENXBIO seeks to accomplish this mission through a combination of internal development efforts and third?party NAV Technology Platform licensees.
