Director - Core Quality Systems Mgmt - Biogen Idec - Cambridge

Job description
A strategic principle for Global Quality is the continuous improvement and modernization of the processes and platforms supporting Biogen Idec’s Quality Systems. This position has the main accountability for ensuring the progress and completion of all approved projects associated with the enhancement of a global platform system supporting any of the Biogen Idec Quality Systems. The position does not remove the accountability of each function within Global Quality to deliver on requirements, process design, project execution and implementation. This position will facilitate the translation of business requirements for support functions (such as IT), provide Global Quality senior management with progress on project execution, manage the portfolio of active programs related to quality platforms, and communicate the strategy to the quality organization.


• Through interfacing with Global Quality organization and external partners such as Global Operations and IT, analyze operations and identify key unmet business needs relating to core quality systems and information management. Leverage established processes to identify gaps, such as the internal audit function, to determine areas that could benefit from continuous improvement or platform re-design.

• Establish a continuous business-driven prioritization system around the unmet needs in a manner suitable for senior managerial review. Responsible for tracking progress and providing updates to senior management to ensure visibility. Manages the portfolio of business systems improvements for the quality organization.

• Through the prioritization system, establish strategic vision for quality system improvements including program plans leading to global implementation.

• Lead management of the program plans with the Global Quality and partner organizations through to completion on schedule and on budget.

• Ensures the availability and clarity of quality business system requirements for support functions working together with quality to improve systems, processes and global platforms.

Qualifications

Requirements
• 10 years GMP experience specializing in quality operations ideally across biologics and small molecule manufacturing and supply chain organizations
• Extensive GMP experience across the entire drug supply stream
• Formal training in operational excellence highly desired
• Knowledge of enterprise quality systems
• Ability to lead in a matrix environment, influencing without direct authority and to communicate the details related to complex systems with clarity.
• Strong communication and program management skills

Education

Bachelor’s degree in science, engineering or related field, Master’s degree preferred

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