Director, Quality Assurance Lead, Europe
Bluebird Bio, Zug
integrated product platforms with broad therapeutic potential
Purpose of the Role:
To drive the implementation and management of an effective and compliant Quality organization across Europe and future markets. He/she plays a key role in commercialization of bluebird bio products by ensuring compliance of Qualified Treatment Centers (QTCs), obtaining the necessary GMP/GDP licenses (e.g. WDL, MIA, Tissue), establishing the appropriate QP/RP footprint, and ensuring readiness and maintenance of bbb’s Quality Management System to meet applicable regulations.
This role is part of the bbb Quality Organization, is a member of the Quality Leadership Team, and reports to the Senior Vice President of Quality in Cambridge, MA USA.
Zug Offices: Dammstrasse 21, CH – 6300 Zug, Switzerland
- Lead the bbb European Quality Unit, including the QP and RP European network.
- Ensure GDP and GMP compliance with regulations and QP/RP requirements as it relates to commercialization of bluebird bio products in Europe and future markets – specifically as is relates to Qualified Treatment Centers (QTCs), Transport Providers, GMP/GDP licenses for the operational foundation the Quality Management System, and collaboration with the Global team on CMO compliance.
- In partnership with bbb’s Quality Compliance department, ensure the efficacy of the bbb audit program by providing input to the program, and as appropriate, participating in the audit program.
- In partnership with bbb’s Compliance department, lead and manage inspection readiness, including hosting inspections within the defined geographic scope. This responsibility includes developing responses to any health authority observations and ensuring timely implementation of any corrective and preventive actions.
- Provide quality leadership and expertise to Regulatory Affairs in the establishments of regional licenses linked to the commercialization of bluebird bio product.
- Provide quality leadership and expertise in the development and oversight of, and adherence to, needed Quality Agreements, both with external partners, as well as inter-company agreements.
- Ensure the bbb Quality Management System is monitored and appropriate for commercial GXP requirements as it relates to the defined geography, QTCs, GMP/GDP licenses, and inter-company operations.
- Are eligible to the RP/FvP role in Switzerland (Responsibilities of Responsible Person according to Swiss 812.212.1 Medicinal Products Licensing Ordinance (MPLO)
- Speak fluent English, other language is a plus
- Have minimum of 10 years of experience in the industry, ideally rare disease area,
- Have experience in Quality Assurance, Quality Systems and/or Quality Operations
- Have Science degree in a scientific discipline is required
- Have 5+ Years Quality leadership experience. A successful track record in managing external partners and batch certification to market
- Present extensive skill in planning and multi-tasking management, and in maintaining composure under pressure while meeting multiple deadlines.
- Present considerable skill in effective verbal and written communications, including active listening skills and skill in presenting findings and recommendations.
- Have autonomous approach. Excellent leadership, team building and management abilities
- Have strong hands-on and doer attitude
- Have the ability to travel on short notice (up to 20% at times)
- Are Swiss based – Able to work full time based in Zug
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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