Global Device Platform Lead – Manufacturing & Tech Transfer

NCBiotech

Zebulon (NC)

Hybrid

USD 143,000 - 238,000

Full time

9 days ago

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Benefits offered by this job

Health care and other insurance"

Retirement benefits

Paid holidays and vacation

Job summary

GSK in the United States (Hybrid) is seeking a Device Lead for Global MSAT Drug Delivery and Aseptic Technology. This role owns the Device platform, driving technology transfer, risk management, and lifecycle management from R&D through manufacturing.

It requires interfacing with suppliers and GSK MSAT site teams to ensure compliant, efficient device production worldwide. You will lead global device strategies, collaborate with Strategy, Procurement, Quality, and Logistics, and push for

Qualifications

Bachelor's in engineering or a science degree.
10+ years' experience in Medical Device Manufacturing environment.
Or Masters Degree with 5+ years of experience in Medical Device Manufacturing environment.
Experience working in a pharmaceutical and/or medical device GMP, regulatory environment, relevant ISO standards plus the specific additional legislation needs for medical devices e.g. DHF, MDR, FDA Medical Device guidance.

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.