Associate Director/Director, GCP QA

Title: Associate Director/ Director, GCP QA

Location: Hybrid (Waltham, MA/Remote)

Reports to: Executive Director, Head of GCP, PV QA

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:

The Associate Director/Director GCP Quality Assurance will provide expertise and guidance on Good Clinical Practice (GCP) and applicable guidelines/regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigation at a pivotal point in the growth of the company as it moves through Phase 3 development and global submissions. The ideal candidate will have experience with health authority inspection readiness & inspection management and work collaboratively with functional stakeholders on a quality framework that is simple, efficient, and agile to drive continuous quality improvement in a growing and changing organization.

Responsibilities:

• Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to clinical development functions and program teams.
• Oversee execution of approved annual GCP audit plan, including supervision of auditors, review and approval of audit reports, and oversight of the observation and CAPA tracking process.
• Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to Senior Management.
• Partnering with and ensuring appropriate oversight of CRO QA.
• Work closely with CRO QA teams on vendor-managed deviations and quality issues ensuring agreed upon timelines are met.
• Support GCP quality event management activities, including deviation investigation, development of Corrective and Preventative Action (CAPA) plans, and CAPA follow-up.
• Participate in quarterly GCP Quality Council meetings, providing feedback to senior management on GCP audit trends, CAPA status, vendor qualification issues, GCP quality management system status, and changes in industry regulations, standards, and practices that impact the quality management system.
• Attend clinical program team meetings and provide consultative support on quality issues, including review of protocols, study-specific plans, and specifications.
• Work with functional stakeholders to plan Standard Operating Procedures and supporting documents across GCP functions, harmonizing processes with GMP where appropriate and ensuring compliance with current and changing regulations.
• Support the GCP Inspection Readiness program, including development of inspection readiness plan, oversight of storyboards, and training on inspection participation and logistics.
• Contribute to company efforts to comply with Global Data Protection Regulations (GDPR).
• Participate in worldwide regulatory inspections.

Qualifications:

• BS/BA degree required.
• 10+ years of experience working in the pharmaceutical industry required, with a minimum of 8 years of hands-on GCP QA experience.
• Must have a highly developed knowledge of GCP related global regulatory requirements.
• Must be able to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems.
• Understands impact of decisions and actions on business and consults with appropriate colleagues and management.
• Strong team player who demonstrates initiative, willingness to roll-up their sleeves, and problem solve.
• Ability to thrive in a fast-paced environment.
• Strong writing skills required, including ability to author documents.

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.