VP, Quality, Operations and Performance

Biogen SANDBOX•Cambridge, MA

About The Position

As a member of R&D Leadership Team, this role will collaborate with other R&D functions, as well as functions outside of R&D including Corporate Compliance, Chief Quality Officer, Finance, Procurement, and Corporate Business Development, to ensure appropriate infrastructure, systems, standards and processes are in place to meet regulatory compliance and deliver R&D goals timely and efficiently. This individual will also lead a team to drive the organization to improve quality, execute efficiently to beat the competition, manage cost and risk, and invigorate the R&D culture. Connecting across the entire R&D group, the individual will be accountable for R&D oversight of activities related to quality risk management, audit and compliance activities, strategic operations, scientific collaborations, cross-functional process health, resource and performance management, and drive alignment with the overall R&D strategy. Quality Risk Management: Oversee and monitor Biogen’s R&D Quality Management System (QMS); provide GxP and operational guidance, direction, and advisory support for functional / regional quality groups. Audit and Inspection Readiness: Develop and execute audit strategy for R&D; provide leadership and coordination for inspection preparation and conduct. Resource and Performance Management: Partner to drive consistent operating and capital expense management in support of the pipeline; develop and monitor key performance and quality metrics to enable efficient delivery of the portfolio. Scientific Collaborations: Partner with functions and stakeholder to ensure Research and Early Development collaborations are appropriately managed and execution is consistent with expectations; partner with key stakeholders on business development in support of diligence and contract development. Monitor and assist asset transfer into Biogen from partner/acquired company. Strategic Operations: Optimize our cross-functional process and operating model including the execution of impactful business process improvement, manage and optimize our site operations including space and lab management. Oversee and ensure optimal value and oversight of key R&D vendor relationships. Proactively manage and deliver literature, data and research services to provide competitive advantage to R&D. Others: Partner with Corporate G&A functions to execute activities and high priority projects.

Requirements

A minimum of 15 years’ experience in biopharmaceutical/pharmaceutical industry with at least 7 years of management experience.
Demonstrated success in planning and implementing complex projects and leading changes as re

Responsibilities

Oversee and monitor Biogen’s R&D Quality Management System (QMS)
Provide GxP and operational guidance, direction, and advisory support for functional / regional quality groups
Develop and execute audit strategy for R&D
Provide leadership and coordination for inspection preparation and conduct
Partner to drive consistent operating and capital expense management in support of the pipeline
Develop and monitor key performance and quality metrics to enable efficient delivery of the portfolio
Partner with functions and stakeholder to ensure Research and Early Development collaborations are appropriately managed and execution is consistent with expectations
Partner with key stakeholders on business development in support of diligence and contract development
Monitor and assist asset transfer into Biogen from partner/acquired company
Optimize our cross-functional process and operating model including the execution of impactful business process improvement
Manage and optimize our site operations including space and lab management
Oversee and ensure optimal value and oversight of key R&D vendor relationships
Proactively manage and deliver literature, data and research services to provide competitive advantage to R&D
Partner with Corporate G&A functions to execute activities and high priority projects