Associate Director, Quality Product Lead
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
ABOUT THE FLOCK
Join our enthusiastic and collaborative Quality organization in the burgeoning ATMP field and use your creative Quality thinking to bring our novel gene and cell therapy platforms to patients! As the Quality expert for our products, you will develop and lead the quality strategy throughout the lifecycle of bluebird bio’s products. The Quality Product Lead on product teams will partner within Quality and across diverse stakeholders in Pharmaceutical Sciences, Research, Regulatory, Clinical, and Program Management. The goal will be to align the functional strategy with program, portfolio, and corporate goals. This role will focus on one of bluebird bio’s life-changing Severe Genetic Disease candidates.
HOW YOU’LL FLY
As a Quality Product Lead bird, you'll help to bring more patients their bluebird days by:
- Providing matrix leadership and Quality expertise to project teams on the development and implementation of novel Quality pathways for all aspects of the manufacturing process: starting materials, plasmids, lentiviral vector, autologous cells and cellular drug product with a keen focus on deliverables, timelines and compliance
- Providing strategic Quality leadership in the creation of CMC sections of major regulatory investigational product and commercial submissions and response to HA queries, assuring that they are complete, scientifically accurate, of high quality and are presented in a way that facilitates both internal and agency review
- Evaluating proposed, regulatory-impacting changes for your program, providing Quality review and change control approval, as well as the development and oversight of the associated change implementation strategy to ensure successful approval in applicable markets
- Ensuring filing and inspection readiness from an end-to-end product lens, and as needed, supporting both site readiness and any applicable interactions with regulatory agencies
- Monitoring and interpreting cGMP regulatory guidelines and trends in the fast moving ATMP regulatory space and incorporating into phase appropriate control strategies for all bluebird bio products
- Serving as the Quality lead to support Product Lifecycle initiatives, APR, Product Robustness Plans, and Product Risk Assessments; supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions
- Ensuring the matrix team’s understanding of and compliance to market specific regulations for your programs; serving as the escalation lead on behalf of Quality to guide and manage challenges to achieve compliant solutions when issues arise
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
- BS/MS in scientific discipline with a technical understanding of biopharmaceutical production and understanding of cell therapy and drug product development and manufacturing
- 12+ years of biologics industry experience in technical, quality, and/or regulatory role(s) supporting programs in pre-clinical phases through commercial, with at least one or more roles (5+ years) in Quality (QA, QC and/or Compliance)
- Direct experience with change control, authoring and/or reviewing biological license/marketing applications and interpreting current regulatory expectations to drive sound quality decision making in a matrix environment
- Strong project management skills and ability to communicate effectively across matrix functions at all levels of the organization, influencing areas not under direct control to achieve shared objectives while balancing speed, quality and risk
- Proficiency in development and execution of strategic decisions, balancing multiple priorities in a fast-paced environment while promoting a culture of quality and continuous improvement
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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