Senior Manager, Document Control and Training
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
The Quality team at bluebird is all about working collaboratively to ultimately reach our goal of serving patients and their families! The Senior Manager of Document Control and Training is responsible for ensuring that document management and training programs are implemented and effectively administered while maximizing efficiency, complying with industry standards, and achieving compliance targets. You will collaborate with local and global stakeholders, providing leadership for the streamlining/maturation of local business processes to provide an enhanced customer experience. Come fly with us as we progress towards our goal of delivering life changing therapies for patients!
HOW YOU’LL FLY
As a Senior Manager of Document Control and Training bird reporting to Associate Director of Document Management, you'll help to bring more patients their bluebird days by:
- Managing the training and document management systems, processes, and initiatives while providing and executing innovative ideas to advance process efficiencies and system improvements
- Ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions
- Managing the Doc Control and Training Systems, logistics, delivery, metrics and maintenance while identifying and effectively resolving quality issues/discrepancies
- Providing oversight of the team and managing their distribution of work
- Managing the Cambridge site’s daily document management and training operations, including (but not limited to) ensuring appropriate documents standards are developed and managed, workflows are processed and documents archived appropriately, training requirements for GxP employees are identified and completed, and new hires are effectively onboarded
- Globally owning and managing the document management and training business processes and the electronic systems supporting GxP documents and training needs, including (but not limited to) scaling business processes to match recent and future growth, developing and seeing through implementation of strategic plans and collaborating with global stakeholders to ensure that current and future processes and systems meet all user requirements
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
- BA/BS, preferably in a scientific discipline with 7+ years of document control and training experience, 5+ of which are in a GxP-regulated industry; 5+ years of management experience
- Experience leading and owning a GxP training program, leading investigations into deviations with CAPA responsibility
- Extensive experience managing Document Control Systems
- Learning Management System (LMS) ownership, implementation, facilitation experience
- Demonstrated excellent facilitation, presentation, instructor skills
- Veeva Quality Vault and ComplianceWire experience strongly preferred
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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