Purpose of the function : To assume the function of quality expert in support to the European Quality Assurance organization, contributing to the deployment of quality and GDP compliance in new markets and participating to the quality management of the established markets.
To contributes to the bluebird bio Quality Assurance operations based in Switzerland that ensures oversight over European and Expansion Markets commercial operations.
The function reports to the Associate Director Quality Assurance, Europe and works in close collaboration with the Responsible Persons (RP) and Qualified Persons at bluebird bio offices.
Location : bluebird bio Zug office, Dammstrasse 21, 6300 Zug, Switzerland About the function : Fulfil the role of Deputy Responsible Person (Fachtechnisch verantwortliche Person, FvP) of bluebird bio Switzerland GmbH Act as Quality Manager for countries where a RP is not required Support the Swiss RP for ensuring compliance of GDP operations managed by the bluebird bio offices in Switzerland in tight partnership with Quality Operations and with the local QP / RP in Europe and Expansion Markets Maintain in collaboration with the European Quality Assurance Team the Quality Management System of bluebird bio Switzerland GmbH and the other European bluebird bio Affiliates Collaborate with Patient Supply Team Europe on the set-up of the Treatment Center network and establishment of operational GDP activities Act as Quality unit for GDP change controls and action items, e.
g. related to set-up of Treatment Centers and Expansion Markets Support the establishment and maintenance of the necessary intercompany Quality Agreements for bluebird bio Switzerland GmbH and other Affiliates, as well as Quality Agreements with Treatment Centers, Service Providers and Contract Manufacturing Organizations Support the establishment of standardized practices for the conduct of Quality Management Reviews.
Provide expert quality input with regards to the compliance of the storage and transport including cold chain management, import / export and supply chain traceability Contribute to initial and periodic re-qualification of suppliers, service providers and customers.
Ensuring that initial and continuous training programs are implemented and maintained. Review of the Product Quality Review (PQR) Support effective work processes for self-inspections, audits, health authorities’ inspections, complaints, recalls and investigation of critical / major deviations which are compliant with GDP guidelines and other applicable regulations.
Provide support for the preparation, the hosting and the answering to authority inspections. Promote and drive continuous improvement Ensure efficient implementation of Quality Risk Management within the scope of responsibilities Provide Quality and Compliance input for European and Expansion Markets to the implementation and operations of the electronic systems used within the geographical scope and with GxP functionalities, verify validation status, review and approve changes to the systems.
Support the Quality Organization for the management of product recalls or mock-recall Job requirements : Eligible to the RP / FvP role in Switzerland (Responsibilities of Responsible Person according to Swiss 812.
212.1 Medicinal Products Licensing Ordinance (MPLO) Fluent in English (business language), German preferred, other language is a plus minimum of 10 years of experience in the industry, ideally all phases from clinical trial management through commercial medicinal product Experienced in Quality Assurance, Quality Systems and / or Quality Operations Bachelor of Science degree in a scientific discipline is required Strong knowledge of Swiss and other global regulations (EU, U.
S., ROW) applicable to commercialization in the geographical scope Extensive skill in planning and multi-tasking management, and in maintaining composure under pressure while meeting multiple deadlines.
Considerable skill in effective verbal and written communications, including active listening skills and skill in presenting findings and recommendations.
Ability to establish and maintain harmonious working relationships with co-workers, staff and external contacts, and work effectively in a professional team environment.
A resilient Quality Leader willing to pave a path Ability to travel on short notice (up to 20% at times) Be ready to embrace the principles of the bluebird bio culture : b colorful, b cooperative, and b yourself bluebird bio is committed to fostering an environment where everyone can be their whole selves and know they are valued.
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