Senior Director, Digital Quality and Data Integrity

Job Title: Senior Director, Digital Quality and Data Integrity

Location: Waltham, MA

Reports To: VP, Quality Operations

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 designing, implementing, and leading the data integrity program governing the handling and management of all GXP data for both manual and computerized systems, and for general quality oversight of GxP computerized systems validation and lifecycle, including quality related procedures, risk assessments, specifications, validation, governing commercial operations.

This individual will drive deep collaboration with global program teams and key product development and commercial partners including CMC Technical Services, CMC Program Management, Supply Chain, IT, Regulatory Affairs, 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:

• Partner with GxP System Owners and IT on the requirements and procedures governing design control of device systems, including design input and output, verification, validation, risk analysis and maintenance of the design history file.
• Responsible for defining policies and procedures for computerized system design, qualification, validation, management, data integrity, ERES requirements.
• Lead gap assessments and remediation plans for all aspects of data integrity on all commercial GxP systems generating or managing GxP data.
• Lead data mapping detailing inputs, outputs and processing of data handling systems.
• Manage external contractors and/or internal resources as necessary to achieve objectives.
• Partner with the GxP System Owner and IT to shape direction on computerized commercial GxP Systems.
• Partner with GxP System Owner and IT to ensure system design and build meet user requirements and computer system lifecycle requirements.
• Establish key performance indicators in alignment with company and operational goals, as well as maintain and report applicable department and delivery metrics.
• Proactively identify and implement improvements to the QMS.
• Participate in internal and third-party audit programs.
• Lead inspection readiness projects and support regulatory body inspections to positive outcomes.
• Recruit and develop team to execute department responsibilities; ensure effective utilization of resources through strong people leadership including consistent performance management, robust employee development and routine rewards and recognitions practices.
• Establish department and individual goals and key performance indicators in alignment with company and functional goals; maintain and report applicable department and quality metrics.
• Support a Quality Risk Management culture. Proactively identify, assess, and mitigate quality, operational, and organizational risks; escalate key risks and issues.

Qualifications:

• Bachelor's degree and 15 years of related biopharmaceutical GMP work experience or Master’s degree and 12 years of work experience. Minimum of 5 years leading quality teams.
• Expertise in commercial cGMP drug regulations; working knowledge of product development and late stage clinical/commercial manufacturing requirements, especially 21 CFR Part 11, Annex 11, and GAMP. Strong knowledge in all aspects of data integrity and computerized systems and software.
• Preferred experience in medical device control.
• Preferred experience in cell and/or gene therapy.
• Demonstrated ability to establish and maintain positive relationships with external partners.
• Ability to define problems, establish facts, and make timely fact-based decisions.
• Extraordinary attention to detail and strong understanding of quality risk management.
• Excellent written and oral communication skills.
• Ability to function in a rapidly changing environment and handle multiple priorities, strong organizational and time management skills.
• Ability to travel up to 30% to support third party audits and inspection readiness activities.

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.