Hiring: Associate Director, Device Lead Company: GSK Location: Waltham, MA Job Posted Time: 2026-09-10 13:52:20 Employment Type: Hybrid Target Skills & Keywords : Assembly, Change Management, R, Risk Management About the job Experience: •10+ years’ experience in Medical Device Manufacturing environment •5+ years of experience in Medical Device Manufacturing environment Required Skills: •Be the SPOC technical SME interface between Device/Component suppliers and GSK MSAT site teams - providing device-related technical management to MSAT where required for business improvement projects and risk management activities, represent MSAT at supplier technical and project meetings. •Deliver a robust supply strategy of Device platform by collaborating with other GSK functions: Strategy, Procurement, Quality, Logistics etc. including the delivery of mold tool & assembly asset validation programmers. •Lifecycle manage the Device Platform, driving Technology Transfer from R&D and maintaining throughout the Device platform life – including post-approval regulatory change management, continued process verification, and continued increase of manufacturing efficiencies and reduction of COGs •Ensure that global device/component manufacturing processes are capable, efficient and meet specification •Support Device Director, Device Strategy and Device Procurement organizations on Continuous Improvement and Business projects within the Global Supply Chain (GSC) to deliver MSAT objectives. •Work cross-functionally to communicate technical global device challenges and successes and influence at all levels including the R&D and supply chain teams to ensure both technical and commercial success of drug delivery devices and integral combination products for GSK. •Perform risk management activities (e.g. risk file review/approval) when working with product and project teams. Lead risk management process as ‘risk owner’ when required. •CMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology Transfer Qualifications: •Bachelors in engineering or a Science Degree (e.g. Process/Mechanical Engineering, Materials Science, Biomedical Engineering/ Chemistry) •OR Masters Degree with 5+ years of experience in Medical Device Manufacturing environment •Knowledge of pharmaceutical development activities and processes adopted by R&D relating to product development, NPS and Technology Transfer. •Good understanding to enable management of device assembly, metrology & plastics testing techniques & procedures and GSK Specification & Drawing systems •Operate independently within their sphere of influence and work with multiple stakeholders across global business units internally and externally •Strong interpersonal and leadership skills. Committed team player prepared to work in and embrace a team-based culture. •Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines. •Strong verbal and written communication skills. •Excellent judgment. Able to priorities and decide appropriate courses of actions. Effective at implementing decisions. Proven track record. •A working understanding of data science including digital data infrastructure, visualization, and statistical analysis Compensation: •$142,725 - $237,875 / year •Flexible work environment (work from home / hybrid options) •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!