Site Name: USA - Massachusetts - Waltham, Barnard Castle, USA - Pennsylvania - Upper Providence, Ware
Posted Date: Apr 7 2026
Responsibilities
* Be the SPOC technical SME interface between Device/Component suppliers and GSK MSAT site teams – providing device‑related technical management to MSAT for business improvement projects and risk management activities, and 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, and delivering mould 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 improvement 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 and regulatory DHF/Technical file requirements to ensure global standardization of Device supply, maintaining an overview of relevant external standards and compliance with internal procedures, e.g. FDA 21 CFR 820, EU 2017/745, 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 to deliver MSAT objectives.
* Work cross‑functionally to communicate technical global device challenges and successes and influence at all levels, including 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, championing business cases for sustainable manufacturing technology implementation or other strategic projects related to quality by design, design for manufacturing, product and process understanding, design control, 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.
Basic Qualifications
* Bachelor’s in engineering or a Science Degree (e.g. Process/Mechanical Engineering, Materials Science, Biomedical Engineering/Chemistry)
* 10+ years’ experience in Medical Device or pharmaceutical Manufacturing environment
* OR Masters Degree with 5+ years of experience in Medical Device or pharmaceutical Manufacturing environment
* Experience working in a pharmaceutical and/or medical device GMP, regulatory environment, relevant ISO standards, and specific legislation for medical devices (e.g. DHF, MDR, FDA guidance)
Preferred Qualifications
* Knowledge of pharmaceutical development activities and processes adopted by R&D related to product development, NPS and Technology Transfer.
* Good understanding of device assembly, metrology & plastics testing techniques and procedures, and GSK Specification & Drawing systems.
* Experience leading device groups in a global matrix environment with a track record of successful global asset lifecycle management.
* Operate independently within 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 prioritize and decide appropriate courses of action, effective at implementing decisions, proven track record.
* Working understanding of data science including digital data infrastructure, visualization, and statistical analysis.
* Knowledge of current GMPs, ICH Guidelines, FDA QSR, and EU MDR device requirements and familiarity with regulatory registration processes by FDA, EMA, and MHRA.
* Specialize in regulations and ISO standards, medical device requirements, and global device and combination product regulations such as 21 CFR 820, EU MDR 2017/745, ISO 13485, and ISO 14971.
* Knowledge of injection mould tooling design & processing, device polymers and materials engineering, springs/wire forming, device testing and lab management, mathematical modelling, and device automated assembly techniques.
* If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $142,725 to $237,875.
Benefits include a competitive salary, annual bonus, participation in a share‑based long‑term incentive program, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
GSK is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service, or any basis prohibited under federal, state or local law.
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