Site Engagement Associate Director developing and overseeing oncology partnerships for clinical trials. Engaging with key sites to ensure high - quality and timely results in clinical research.
About the role
- Device Lead managing the Device platform and ensuring device delivery for GSK Manufacturing sites across global locations. Leading cross-functional collaboration for technical success in drug delivery devices.
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 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 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.
Requirements
- Bachelor’s in engineering or a Science Degree (e.g. Process/Mechanical Engineering, Materials Science, Biomedical Engineering/ Chemistry)
- 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.
- 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 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 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
- Knowledge of current GMP's, ICH Guidelines and FDA QSR and EU MDR device requirements and familiar 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, Mathematic Modelling, Device automated assembly techniques
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
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