Senior Manager, Quality Assurance, Europe
Bluebird Bio, Zug
integrated product platforms with broad therapeutic potential
Join bluebird bio’s enthusiastic and collaborative Quality Assurance team to contribute to the overall success of our novel gene therapy. As a key member of bluebird’s Quality team, the Senior Manager, Quality Assurance will be responsible for supporting implementation of GxP compliance strategies ensuring compliance with global regulations in the EU. This position will be an integral member of the Quality Assurance team situated in bluebird’s European office in Zug, Switzerland. The position is new to bluebird and will be mainly focused on Good Distribution Practice with interactions in areas of Good Manufacturing Practice, Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Tissue Practice (GTP).
Quality interactions will be applied to bluebird bio Affiliates sites and to Treatment Centers in both clinical and commercial background. Direct and applicable knowledge of European, US and global requirements within both clinical and commercial lifecycles is required.
bluebird bio’s Quality Assurance team partners with all other departments within bluebird bio both in the US and EU, and strong interpersonal skills are a must. The ability to pivot priorities and areas of focus while maintaining momentum on all initiatives to drive completion of projects is vital to the success of this role. Additionally, this role will report to the European Lead, Quality Assurance and work closely with Technical Operation, Treatment Centers and Procurement to aid in supplier quality.
The Quality Assurance, Senior Manager will be very important to the success of the company. This position will be a member of the Quality Assurance Team working in the Zug, Switzerland office.
About the role:
- A highly visible role expected to embrace bluebird bio’s Core Values; b colorful, b cooperative, and b yourself (bluebirdbio.com)
- Supporting Swiss RP and deputy in their duties to fulfill Swiss regulations
- Assist the Quality Compliance function by performing external audits
- Acting as Quality Assurance manager at Affiliate level
- Supporting inspection readiness, including inspections for bluebird bio in the EU
- Supporting Regulatory Affairs and Quality Assurance group to aid in the establishment of licensing as required for commercial product in the EU
- Collaborate and interact with various departments and levels of management to accomplish company objectives
- Ensure the Quality Management System is monitored and appropriate for both clinical and commercial GDP/ GMP/GCP/GTP within the bluebird European network, including Switzerland, Germany, France and the UK and provide training as applicable
- Drive continuous improvement through the monitoring of Affiliates and Treatment Centers metrics
Interactions for enterprise systems in both supply chain management as well as patient chain of identity in the EU. Provide Quality Assurance support for both Affiliates and Treatment Centers
- Excellent communication skills
- Ability to speak English, either German or French, a strong positive
- Collaborative with partners to advance the bluebird bio mission
- Proven experience in Quality Assurance, Quality Systems and/or Quality Operations
- Strong knowledge of global regulations (EU, U.S., Japan) in GDP/GMP environment
- Bachelor of Science degree in a scientific discipline is required
- A minimum of 10 years of experience in the industry, ideally all clinical phases through commercial drug product
- Ability to Travel on short notice (up to 30% at times)
- Eligible to work in Switzerland
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself.
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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