Associate Director, Quality Compliance
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
Associate Director, Quality Compliance
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 7 countries with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our flock 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
The Quality Compliance flock is all about supporting regulatory agency inspections and partner audits. Whether it’s making assisting with responses to inspection findings, maintaining the Approved Vendor List (AVL), supporting inspection readiness efforts across bluebird bio operations, or managing the Auditor Qualification Program, we are always driven by our patients. Come work with a hardworking and collaborative group of birds that love rising to the challenge!
HOW YOU’LL FLY
As a Quality Compliance bird reporting to Senior Director of Quality Compliance you'll help to bring more patients their bluebird days by:
- Leading, developing, and implementing compliance strategies in alignment with global regulations
- Driving, executing, and following up on Apheresis and Treatment Center audits
- Supporting GxP regulatory inspections as required
- Helping to run the GxP Audit Program
- Working with the Apheresis Operations, Commercial and Clinical Development teams to coordinate and prioritize Treatment Center audits
- Monitoring industry inspection trends, new or revised regulations and guidance for impact to bluebird bio operations
- Maintaining the Approved Vendor List
- Assisting with inspection readiness efforts
- Successfully ensuring audit observations are communicated, tracked and remediated in compliance with internal policies as well as with all applicable regulatory requirements
- Assisting with the development, maintenance and execution of the annual audit plan
- Providing performance reviews, development plans and set goals for department staff in alignment with company goals
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Have a Bachelor of Science degree in a scientific discipline is required with a minimum of 12 years of industry experience
- Are experienced in gene therapy, cellular therapy, GVP or GCP
- Are familiar with the application of GTP and GMP regulations (US & EU) and FACT/JACIE requirements
- Have excellent management skills within a Quality Assurance, Quality Systems, and/or Quality Operations environment
- Ability to build relationships and influence across disciplines and all levels, a desire to share expertise and mentor junior members of the team, and enjoy a collaborative team driven by the bluebird bio mission
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.
Innovative, fast-paced, challenging.. we're everything you want in a workplace.