Director SaMD & Digital Standards, Open to flexible working
As the world becomes increasingly digital, Medical Devices are now moving from being purely physical objects (e.g. a blood pressure gauge) to physical and software hybrids, or even a pure Software as a Medical Device (SaMD). This evolution is being addressed by legislators with new laws that are extending Medical Device legislation into how applicable software is designed, built, tested and supported .
As the Pharma Tech leader for all SaMD initiatives you are recognised formally as the point of contact for SaMD matters raised to Pharma Tech, related to the creation and implementation of software in accordance with SaMD regulations Globally (e.g. FDA, EMA, PMDA etc..), Tech Standards and SOPs.
Representing Pharma Tech in cross-functional workstreams looking at how to improve the existing internal control frameworks. You are responsible for ensuring decisions made in x-functional SaMD workstreams are brought back and executed within the Pharma BU as agreed.
The role is applicable globally for all in-scope Pharma Tech related SaMD activities and will support the Pharma Tech Leads in the Local Operating Countries (LOC's) for notifications and guidance from the Global teams for SaMD development and implementation activities. In addition, the SaMD Lead serves as first line support and internal contact to their Pharma Tech & line management who are responsible for SaMD initiatives.
Initially, this roll will:
- Design and drive the implementation of the SaMD management plans for Pharma Tech through a program of work designed to strengthen the internal control framework, Report compliance progress and gaps to Pharma Tech Leadership and secure executive support (budget & resources) to implement.
- Prioritise and lead Pharma Tech to adopt processes vital for compliance with SaMD, Standards and SOPs
- Provide direction to LoC BU Risk Management and Compliance Boards, line management and employees to ensure compliance with SaMD aspects related to Standards and SOPs within existing ways of working.
- Specify and monitor that required training is performed by employees (who require it for their work on SaMD) in Pharma tech and input to the training materials to ensure that these are relevant.
As projects complete and the internal control framework is strengthened, this role will:
- Ensure that SaMD is discussed at Pharma Tech RMCB (Risk Management Control Board) and its plans will include SaMD aspects and secure executive support to implement as required.
- Provide direction to functional leadership and Pharma Commercial leadership to ensure that GSK follows SaMD guidelines. Including support of SaMD Assessments for Global and LoC initiatives related to SaMD activities.
- Prioritise and lead functional initiatives to modify business processes necessary for compliance.
- Accountable for strengthening the internal control framework related to SaMD matters for Pharma Tech specifically, and contribute to global control documents governing all Pharma Tech SaMD work. You will create Pharma Tech specific documents where required and/or ensure relevant steps needed to strengthen the SaMD Framework are embedded in existing control documents and process steps.
- Responsible for coordination of internal control documents implementation in alignment with business needs across all countries in the function.
- Stay current with SaMD regulations that affect the function's business processes across priority markets (Tier 1 and Tier 2)
- Serve as Tech liaison in partnership with Regional or Global Teams (Regulatory, Medical, Tech Risk, Quality Assurance, Ethics and Compliance) to advise on best practices and approach to handling SaMD.
We are looking for individuals with these skills to achieve our goals!:
- Previous experience working in a function where SaMD controls were in place is critical but SaMD is a new and emerging field so the experience may be of relatively short duration. Additional experience of software in regulated environments is advantageous (SoX, GxP)
- A detailed appreciation, and experience of, the full S/W development lifecycle is important to understand and mitigate risks from sub-optimal practices.
- A solid understanding of the implications upon software development required by SaMD will help inform approaches to improve the existing control framework.
- Ability to assess, organise, prioritise, estimate, execute and deliver results on a variety of concurrent activities (program management)
- Ability to lead and empower multi-functional, interdisciplinary teams to achieve tactical and strategic goals through matrix leadership.
- Strong problem solving skills that are pragmatic, which demonstrates a solid understanding of the business.
- Great interpersonal skills with the ability to influence individuals at all levels of the organisation in a highly matrixed organisation across geographies and cultures
- Excellent written and verbal communication skills; ability to communicate Compliance and risk-related concepts to technical and non-technical audience.
Interested in Joining the Team?
Please apply via our online portal providing your CV and Cover Letter.
Please ensure you apply before the 9th May 2021 to ensure you're in the running!
(Please take a personal copy of the Job Description, as this will not be available online post closure of the advert)
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