Device Lead, Global MSAT Drug Delivery and Aseptic Technology
Technical owner of the Device platform and globally accountable for Device delivery into GSK Manufacturing sites from the Supply Base. The role requires flexibility and the ability to adapt to the resource needs of the business, including international travel where applicable.
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 the Device platform by collaborating with other GSK functions: Strategy, Procurement, Quality, Logistics, etc., including the delivery of mould tool & assembly asset validation programmes.
* Lifecycle manage the Device Platform, driving Technology Transfer from R&D and maintaining through 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 compliance with internal procedures relating to device manufacture, supply and risk (e.g., FDA 21 CFR 820, (EU) 2017/745, Medical Device Regulation (MDR), ISO 13485, ISO 14971, 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 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, 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 and lead risk management process as "risk owner" when required.
Qualifications
Basic qualifications
* Bachelor's in engineering or a science degree (e.g., Process/Mechanical Engineering, Materials Science, Biomedical Engineering/Chemistry).
* 10+ years' experience in a medical device/pharmaceutical manufacturing environment.
* OR Masters degree with 5+ years of experience in a medical device/pharmaceutical manufacturing environment.
* Experience working in a pharmaceutical and/or medical device GMP, regulatory environment, relevant ISO standards plus specific additional legislation needs for medical devices (e.g., DHF, MDR, FDA Medical Device guidance).
Preferred qualifications
* 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.
* Experience leading device groups in a global matrix environment with a track record of successful global asset lifecycle management.
* 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 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.
* A 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, device automated assembly techniques.
Benefits and Compensation
The US salary ranges for new hires in this position are $142,725 to $237,875, depending on location, skills, experience and education. Additional compensation includes an annual bonus and eligibility for a share‑based long‑term incentive program. Benefits include health care and other insurance for employees and families, retirement benefits, paid holidays, vacation, paid caregiver/parental leave and medical leave.
Equal Opportunity Employer
GSK is an Equal Opportunity Employer. This ensures that 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 (including family medical history), military service or any basis prohibited under federal, state or local law.
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