Global Device Platform Lead

GSK; United States; On-site; USD 130,000 - 170,000; Full time

Job summary

GSK is seeking a Device Lead of Global MSAT Drug Delivery and Aseptic Technology. You will own the Device platform, drive technology transfer from R&D, and manage device risk and lifecycle across global manufacturing sites.

Travel may be required to support international operations and regulatory activities. The role requires deep experience in medical device GMP environments, strong cross-functional leadership, and a track record of delivering compliant, cost-efficient device solutions.

Qualifications

• Bachelor's degree or higher in a relevant engineering/science field.
• 10+ years in Medical Device Manufacturing or 5+ years with a Master’s.
• Experience in GMP, regulatory environments (FDA/ICH/MDR) is required.
• Knowledge of DHF, ISO 13485, ISO 14971, FDA QSR is preferred.

Responsibilities

• 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
• Own and maintain the Device design including regulatory DHF/Technical file requirements to ensure a global standardization of Device supply, maintaining an overview of relevant external standards and maintain compliance with internal procedures relevant to device manufacture, supply and risk, e.g. FDA 21 CFR 820, (EU) 2017/745, Medical Device Regulation (MDR), ISO 13485, ISO 14971, and ISO 10993.
• 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.
• Drive innovation through the introduction of new and novel device technologies and/or ways of working and champion business cases for sustainable manufacturing technology implementation or other strategic projects including those related to quality by design, design for manufacturing, product and process understanding, design control, and digital data management, and analytical competency.
• 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.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

Quality by Design

Risk management

Project management

Verbal and written communication

Education

Bachelor's in Engineering or Science

Master's Degree in Engineering with 5+ years experience

Job description

GSK is seeking a Device Lead of Global MSAT Drug Delivery and Aseptic Technology. You will own the Device platform, drive technology transfer from R&D, and manage device risk and lifecycle across global manufacturing sites.

Travel may be required to support international operations and regulatory activities. The role requires deep experience in medical device GMP environments, strong cross-functional leadership, and a track record of delivering compliant, cost-efficient device solutions.