Community Leader
3 weeks ago
The primary role of MSAT Respiratory Devices Lead is to ensure that global respiratory device manufacturing processes are capable, productive and compliant in making high quality products for patients. MSAT Respiratory Devices Lead oversees the technology transfer of respiratory devices from R&D, third party clients, and external Contract Manufacturing Organisations (CMOs) to and from GSK to other manufacturing sites. MSAT Respiratory Device has responsibility for oversee lifecycle management for all respiratory device assets manufactured internally and externally, including technical, design control, verification and validation documentation, regulatory submission, inspection, and audit support. The MSAT Respiratory Devices Lead also has direct responsibilities for DHF maintenance and continuously improved product quality.
MSAT Respiratory Devices Lead sets the strategic vision for the global MSAT respiratory device team, in alignment with the GSK network strategy team, and has an accountability to develop a high performing respiratory device team capable of delivering MSAT commercial product objectives. The MSAT Respiratory Device Lead will be engaged in technical strategic objectives across the network and will be required to work collaboratively within GSK internal global sites and with external CMO teams to deliver these strategic imperatives.
Responsible for the technology transfer and introduction of new processes globally and has direct accountability for the global respiratory device assembly technology transfer and validation activities to deliver an asset that can achieve yields and product attributes necessary for meeting commercial supply demand.
Responsible for lifecycle management for all respiratory device products commercially managed at global sites including post-approval regulatory change management, continued process verification, DHF maintenance and continued increase of production yields and decrease of COGs.
Provide technical input to enable site selection and sourcing decisions on current and potential new products and components from GSK or contract partners to be made.
Responsible for the supply assurance of Ellipta dry powder inhalers, Diskus inhalers, Metered Dose inhalers, intranasal devices for the commercial GSK Respiratory product portfolio.
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.
Maintain overview of relevant external standards and maintain compliance with internal procedures and regulatory requirements relevant to device manufacture, supply and risk.
MSc or BSc in Mechanical Engineering, Process Engineering, Materials Science, Biomedical Engineering, Chemistry or other appropriate field and extensive professional experience.
Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines.
Strong verbal and written communication skills which emphasize teamwork with a strong quality orientation.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. recruitment@gsk.We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.
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