Head of Quality, Device and Combination Products

Job Description

This Global Quality group is looking to hire a Global Head of Quality Device and Combination Products to be the primary lead for development of device quality business strategy including business quality strategy for external partners and collaborations.  This person will establish cross-functional roles and responsibilities (within Biogen and across companies) and have accountability for execution of all strategic imperatives. This employee will be the primary quality representative for external partners and collaborations with a device or combination product scope.

He/She will lead the Global Device Quality department which is responsible for all Quality aspects of Combination Products and devices including Design, Development, manufacturing, testing, release and lifecycle management of device and device component / constituents. This person will manage a team responsible for the quality oversight of design control and risk management activities for combination products (including digital health), medical devices, device components and packaging and distribution operations. This person will develop its direct reports and its organization to ensure uninterrupted supply of product.

This is a hybrid role that will be based in either our RTP, NC office or Cambridge, MA office.

What You’ll Do

• Design and implement quality business strategies for internal programs and programs associated with external facing partners. 
• Lead department responsible for global quality oversight of all aspects of combination products and devices. Responsibilities include oversight of all design partners, clinical and commercial Device manufacturing CMOs, as well as development and management of a robust QMS supporting compliant manufacture, launch and global management of combination products and devices. 
• Manage and develop quality team responsible for technical and quality support for design, development, manufacturing operations, deviations management, change management, risk management, investigations for product / quality system failures, to ensure on-time execution of transactional activities
• Lead quality team responsible for quality engineering guidance and oversight for medical device and combination products during feasibility, all phases of design control, risk management, human factor/usability engineering, process development and verification/validation testing, as well as lifecycle management during design changes.
• Lead or support sustainable, continuous improvement to the device and combination product Quality Management System and best practices for device lifecycle processes, quality and supply chain operations by identifying areas for improvement and engaging in remediation.
• Manage QA oversight of clinical packaging sites, medical device or device component suppliers, development partners and testing partner by providing technical and quality support during the development, testing and manufacture at a supplier site. Prepare and manage quality agreements.
• Provide Quality expertise to influence and support decisions across the Biogen Supply Chain. Perform functions and ensures their team makes decision consistent with cGMPs, QSR, ISO 13485, Good Distribution Practices (GDP) and Biogen's quality governance.
• Support internal audits, certifications, external audits of CMOs and facilitate regulatory inspections at Biogen and it’s CMOs.

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or relevant degree with a minimum of 12 years of experience in medical device quality, engineering and/or packaging experience. Equivalent education and experience may also be considered.
• 5 years of experience in clinical quality operations and/or device quality.
• Comprehensive knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971 and ICH Q9, ISO 11608, ISO 62366, ISO 10993. ISO 26304 is a plus. Also, the EU Medical Device Regulation, GMP and GDP regulations and subsequent applications to medical device development and/or packaging operations.
• Expert understanding of CMO mediated Supply Chain activities including process, technology transfer, and routine operations
• Experience in engaging with regulatory authorities and notified bodies
• Experience in people management (>5 year) and project management
• Experience working in international matrix environments

Who You Are

You are an experienced leader with in-depth knowledge of Quality with experience in device and/or combination product processes, clinical packaging, and documentation. You have the ability to develop strong relationships with internal and external counterparts with effective interpersonal skills. You are able to make a high impact to ensure Biogen’s ability to supply safe products to patients on-t