Director, GxP System Owner

Job Title: Director, GxP System Owner

Location: Waltham, MA

Reports To: Head of CMC Program Management and Operational Excellence

About AlloVir

AlloVir is a publicly held, high-growth biotechnology company pioneering science in the field of virus-specific T cell (VST) therapies.

We embrace a shared mission to prevent and defeat life-threatening viral disease, champion truth, and challenge the status quo in pursuit of constant improvement.

Our innovative spirit lives beyond the lab, in a world where patients fighting viral infection have access to revolutionary allogeneic cell therapies. A world where everyone has access to a healthy immune system.

Success in this role means partnering across the organization to establish an innovative cell therapy manufacturing supply chain, taking a pro-active approach to identifying and overcoming risks and barriers, and challenging in the pursuit of continuous improvement.

At AlloVir, the expectation is that regardless of title, people are both group leaders and individual contributors. Much like medicine, we believe that this person can both do the work and set the work, working across functions seamlessly, sometimes in the lead position sometimes in support.

The Role:

This position is responsible for oversight, management, and lifecycle of key CMC software systems including software devices/systems for analytics, quality, data visualization, CytoMatchTM. Lifecycle ownership takes into account the strategy, design, and control, as well as driving towards implementation of innovative solutions to meet compliance and business needs.

This individual will drive deep collaboration with global program teams and key product development and commercial partners including Regulatory Affairs, Quality, Supply Chain, IT, and other key internal and external stakeholders. This position requires an individual capable of organizing a complex network of interrelated deliverables and working cross functionally inside and outside the business to deliver transformative cell therapies to patients.

Responsibilities:

• Responsible for the systems’ overall performance, functionality, and maintenance.
• Lead and shape direction on the systems with key partner functions across development, commercial, clinical, and manufacturing, that accounts for and integrates the company strategic goals.
• Partner with key end users to ensure system functionality and interfaces meet customer needs.
• Partner with IT to ensure system design and build meet user requirements and computer system lifecycle requirements.
• Partner with QA Validation to ensure that system design and qualification meets GAMP 5 and AlloVir QMS requirements.
• Responsible for the design control of the systems, including design input and output, verification, validation, risk analysis and maintenance of the design history file.
• Oversee, manage, and drive the execution of the roadmap/projects for on-time and on-budget delivery.
• Manage business relationships with development and commercial partners to ensure clear objectives, and drive efficient decision-making and progress.
• Review and/or author business and technical documents and reports including contracts, specifications, protocols and procedures, quality investigations, change controls, training materials, and global regulatory filings.  
• Conduct business analyses to define value and opportunities for current and new products and features.
• Establish and define design control standards and principles for development and lifecycle management of device products.
• Facilitate efficient and sound decision-making throughout the development and lifecycle process to ensure the device products and features are aligned with user needs, business needs, and established design principles.
• Establish key performance indicators in alignment with company and operational goals, as well as maintain and report applicable department and delivery metrics.

Qualifications:

• Bachelor's degree and 12-15 years of related biopharmaceutical work experience or Master’s degree and 10-12 years of work experience.
• Minimum of 5 years of product/project/program management experience
• Minimum of 7 years leading CMC program/project teams in fast paced environments.
• Strong knowledge in Data Integrity and computerized systems/software validation
• Preferred experience in cell and gene therapy
• Expertise in commercial cGMP drug regulations; device regulations, working knowledge of product development and clinical manufacturing requirements. 
• Excellent communication and negotiation, strong presentation, problem solving, and facilitation skills
• Demonstrated ability to manage cross-functional teams and inspire collaboration across the business.
• Exceptional organizational and time management skills; ability to multi-task in fast paced environments.

Why join AlloVir?

AlloVir is the global leader in developing novel cell therapies that restore natural immunity against life-threatening viral diseases for immunocompromised patients.

We have an innovative pipeline of allogeneic, off-the-shelf, T-cell therapies that treat and prevent many devastating and life-threatening viral diseases. Our technology and manufacturing process enables the potential for the treatment and/or prevention of up to six devastating viruses with each single allogeneic cell therapy.

As part of the ElevateBio portfolio of companies, you’ll have access to award-winning facilities with centralized cell and gene therapy manufacturing capabilities that help advance the development of our revolutionary therapies for immunocompromised patients.

Join a team committed to scientific excellence, focused on passionate engagement, and united in purpose to treat and defeat viral diseases.

At AlloVir, we are committed to fostering and expanding diversity in the workplace. We strive to create an environment where everyone feels a sense of belonging and differences are celebrated as strengths. With a company vision of “ImmUnity for all”, we place special emphasis on unity, on equality, and on inclusion for all employees, patients, and partners.

AlloVir is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. AlloVir will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.