What are the responsibilities and job description for the Executive Director, Site Quality Head position at ElevateBio?

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role :

We are seeking an experienced Site Head of Quality to lead and establish the Quality function at our Pittsburgh BaseCamp GMP Manufacturing Site, currently under construction. This site is in addition to our established GMP Manufacturing Site in Waltham, MA for cutting-edge cell and gene therapies. The Site Head of Quality will be responsible for building and leading the Quality team, ensuring GMP compliance, and driving continuous improvement. As a key member of the site leadership team, you will partner with the Site Head to integrate quality standards into all site operations. Additionally, you will contribute to refining BaseCamp policies across the sites through participation in Communities of Practice.

Here's What You'll Do :

Startup Support : Support the startup of the facility through Quality oversight of commissioning, qualification, and validation activities, ensuring that quality systems and processes are fully operational upon facility launch.
Team Leadership & Development : Build and lead the Quality team, recruiting, training, and developing talent in Quality Assurance (QA) and Quality Control (QC). Foster a collaborative, high-performance Quality culture across the site.
GMP Compliance & Oversight : Ensure the site complies with all GMP regulations, maintaining inspection readiness throughout product lifecycles. Lead regulatory inspections (FDA, EMA, etc.) and client audits.
Quality Systems & Improvement : Oversee the development and maintenance of site-specific Quality systems. Lead continuous improvement efforts to optimize quality assurance and operational efficiency.
Collaboration & Site Leadership : Partner with Manufacturing, MSAT, Facilities, Engineering, IT and other departments to integrate quality across site operations. As a member of the site leadership team, collaborate with the Site Head to align on strategic goals and quality priorities.
Client Programs Collaboration : Collaborate with Business Development and Program Management teams to support Quality aspects of client-contracted programs, aligning with client expectations and project timelines.

Requirements :

Bachelor's degree in a scientific discipline with at least 15 years of experience in a pharmaceutical, biotechnology or biologics operation, including 10 years of experience in GMP Quality settings.

Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Advanced Therapies including Cell Therapy, Gene Therapy (Viral and non-viral), and RNA therapy products and aseptic manufacturing processes preferred.

Experience in working in a Contract Manufacturing environment preferred.

Working knowledge and demonstrated ability to apply GMPs across early and late clinical phases.

Excellent communication skills with a customer service mindset.

Strong leadership, teamwork and problem-solving skills.

Experience leading and training others in root cause investigations, deviations, OOS and CAPA.

Technical proficiency & knowledge in use of enterprise electronic data management and execution systems (i.e. ERP, QMS, DMS, LIMS, and MES).

Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission :

To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision :

We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.

ElevateBio 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. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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