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Status update

Jul 30, 2020

Mark Glass
Head of Business Development EU, SGS

Welcome, everybody, and thank you for joining this SGS Life Sciences presentation on how to expedite the implementation of insource technical teams in GxP environments. My name is Mark Glass. I'm presenting today, and I head up our Business Excellence Center, which is a central support function for our Life Sciences network, which includes the delivery of insource projects. And this is where we recruit, we deploy, and then manage technical teams who are providing some sort of functional service into our clients' facilities. And this work is typically undertaken on a medium to long-term basis to support our clients' operational activities. Today's agenda is broken down into four main sections. Firstly, we want to consider insourcing as a managed service. Secondly, we want to go through the process of really defining project scopes, that contractual process that ensures we really understand the resourcing and technical needs of the client.

And thirdly, to ensure that these projects are delivered on time, it's essential that we have effective expedited recruitment, and we're going to talk about the key elements to enable effective timely onboarding of technical staff. And then finally, we're gonna consider governance. Governance is the process through which we deliver continuous improvement, we ensure effective communications with our client, and that our performance is appropriately managed and delivered. So let's consider what are the drivers for insourcing as a managed service. So what are the things that make us need to manage our resources when we deploy them into our clients' locations? And this has a lot to do with the specific needs of the life sciences industry, which is increasingly using contingent workforce solutions, i.e., managed insource services, to reduce cost, permanent headcount, support ongoing capital investment, and commercialization activities by accessing variable human resources.

To support this effectively, resource providers need to have a strong operational and regulatory compliance knowledge of the client operations and be able to add value through ongoing technical support and governance. So the service provider really needs to understand customer needs within a regulated environment. Additionally, these deployments have a supervisory component to mitigate co-employment challenges, which can only be effectively delivered again with direct operational understanding of client activities. So let's consider what is a managed insource solution. Well, first of all, they are medium to long-term projects. So assignments of six months typically is a minimum, often, being permanent deployments. They may vary in size over time, but often, these deployments result in a permanent, functional service.

There is typically a minimum of two FTEs, two people involved, and that enables on-site supervision but also the provision of off-site management from a technical and supervisory perspective. We've been providing technical quality professionals and support staff for deployment within regulated environments, be it GxP or ISO, within R&D or commercialization, manufacturing functions of biopharmaceutical and medical device companies. The resourcing can be global in nature, and we provide contract and payroll infrastructure and the general induction before site-specific client training. The project is managed on an ongoing basis, and a key component of that is governance, where we use KPIs to monitor, manage, and improve performance over time. And then, as I said, the managed service involves off-site management that can provide technical oversight and assistance in collaboration with the client.

So with those things considered, what are the key elements for successful implementation of an insource solution? So it needs to combine scientific operational knowledge and progressive recruitment expertise and the infrastructure in order to do that. You need dedicated people, dedicated project delivery, and relationship management resources, and global coverage, offering regional expertise in both technical and recruitment compliance while leveraging centers of excellence and learning from best practice across the organization. This graphic represents our global presence and the locations we have that deliver our managed insource solutions. There are two basic types. One are our SGS offices, where we have recruitment and project management professionals who work in each project liaising with the client to deliver the requirements. And then secondly, we have our global network of life laboratories, where we have technical operational quality professionals who support our insource projects from a technical oversight perspective.

That combination of regulated life sciences laboratories and dedicated recruitment and project management locations allows us to deliver a service globally, but with the understanding of local regulatory and recruitment requirements. To ensure a successful project initiation and management, it's really important that you have a clearly defined project scope and a contractual process from definition to delivery. As I said, there are often regional considerations to be made when looking at these projects. It's important to have a regional contractual framework, and that ensures compliance with variations in local regulation. It's important that the functional requirements, the activities that the client is requiring resource support on, are interpreted correctly and are fully understood. Part of that is then a risk assessment.

Once those functional requirements are defined, a risk assessment needs to be undertaken, both from a scientific or technical perspective but also a recruitment one, to understand the feasibility of identifying the appropriate resources in the appropriate time frame. From that, then, we would develop a resource and delivery plan. When considering ongoing project management, we would decide what are the critical measures and KPIs to use and what cadence of governance, how often would we engage with the client to ensure ongoing performance delivery. Then we would describe those commitments, those services, and service levels in a SLA, a service-level agreement, which we would sign with the customer for a specific project. So once we've gone through that, scoping of project requirements and the contractual process, we will have developed a proposal.

That proposal will have key elements which demonstrate the parts of the project that require clear definition and understanding. This is typically done under the scope of a master services agreement, and appended to it as a specific project scope of work. First of all, to reflect the functional requirements and how we organize ourselves, there would be an organizational chart with implementation milestones. The points at which we would onboard specific individuals or resources to support the project and where the people will fit in that organizational chart to deliver the service. With each individual within the organizational chart, we will have profiles of the individuals and their corresponding job descriptions, and then functionally what they will deliver in terms of service. That's described through key performance indicators and the ongoing review through governance.

We would also describe the employment contract types for each individual within the organization chart, and they will vary from temporary types of employment through to permanent. Again, it's having our global contractual framework in place that allows us to define those employment types and options, quickly and clearly to the client. Then, of course, the charges, the costs, for the work. That can be defined per resource required, but also it can be associated with the deliverables that are part of the overall service provided by the insource team in place. There would typically be a minimum duration that would be defined in the proposal and then a change control mechanism. The idea of a contingent workforce solution is that they are flexible, and they can change to meet ongoing client requirements.

And so we have a clear mechanism of change control where we can vary the types, size of the teams, and resources, accordingly. So now that we've considered insourcing as a managed service, I want to focus on a key element of the overall project delivery model, and that's effective expedited recruitment. If we can't identify appropriate personnel and resources quickly, as these projects are always time-sensitive, we won't deliver on our client's expectations. To understand resource requirements, search and onboard effectively, the following elements really need to be in place. We've got to have dedicated teams for technical and recruitment assessment and proposal development. So those are scientific staff and recruitment teams working collaboratively to assess both operational technical elements and the recruitment and human resource aspects of the project.

We need to have proactively developed profile templates, job descriptions, and have those organized in the database so that they are quickly and easily accessible and reflect the expected client requirements that we typically encounter within the biopharmaceutical and medical device industry. With those profiles defined, we can recruit proactively. What we do is create candidate pools, which are identified candidates for technical areas and specialisms that we expect to be required to deliver for our clients. That means that we've done some base work in terms of recruitment and identifying appropriate resources when specific project requirements are defined. To facilitate that, we use technology. We use applications to allow us to interact effectively with our clients and the candidate population. I'll describe that in a later slide in more detail.

It's very important, as I've said, that you have regional understanding of the differences in recruitment market requirements. And then to be able to support that from a payroll and a contractual process is critical. And then there are a number of specific elements that need to be supported: insurance, medicals, HSE, generic induction processes, and having the infrastructure and arrangements in place to be able to provide those components as part of the overall service. One of the key elements that I mentioned before was proactive recruitment and candidate pooling. And this is a slide that indicates the functional areas that we would focus on when we're proactively identifying candidates in the employment market. So it may be from a regulatory perspective, managers or associates, general project management. On the more operational and laboratory side, it could be support staff, managing samples.

It could be QC analytical within different technical areas such as microbiology, chemistry, biochemistry. It could be more developmental activities like method development and validation, environmental monitoring, manufacturing support, or potentially stability program management. When we have deployed teams in these areas, we would always have a supervisory role offsite and an on-site manager responsible for the overall cadence of governance. The recruitment platform is the technology that we use, the application that we use, to manage different aspects of the recruitment activity. We like to have a clear audit trail for applicant tracking so we know exactly where any particular applicant is in terms of the overall onboarding process. The platform is also a storage facility for all related documentation related to recruitment for the project.

It also allows us to search keywords on our CV database to expedite recruitment and allows us to manage the contractual process and the interactions with the client when we're progressing that activity. The platform always also provides a portal, an access point, both for clients and candidates to interact with that, either to change scope of a project, or define profiles or job descriptions, or to make applications and provide necessary documents like resumes or CVs for a particular position from a candidate. We can use the application to actually post job requirements within the overall project. In addition, it's integrated with other related platforms, so that we provide a seamless onboarding experience for our candidates, including integration with payroll software.

So in summary, our recruitment platform is an application that allows us to manage the three key components of an insource delivery model. First of all, the interface with the client so we can clearly define and manage the delivery of projects. Secondly, it allows us to effectively manage the operational aspects of recruiting and onboarding. And then thirdly, it gives us a very expeditious and effective access to the recruitment market and potential candidates for any given project. And in doing so, it gives the stakeholders access to key information in real time. Once initial recruitment activity is complete, it's essential that governance and performance management are supported appropriately. There are some key elements to this. There needs to be an objective assessment of performance through the use of KPIs and implementation of resultant improvement initiatives and actions. And this is essential for success.

Within that, there must be clear roles and responsibilities between the client and the service provider, and there must be a regular cadence of review between the parties with a very structured agenda. There needs to be a defined process for issue escalation and problem resolution. The KPIs need to reflect both technical, you know, operational requirements and also human resource aspects. And as we mentioned before, this needs to be encompassed within a clear service-level agreement between the parties. So this is an overview of a typical governance process. So we often have a monthly review, which will involve the distribution of a periodical KPI report, and then quarterly face-to-face stakeholder engagement. It's important to have appropriate stakeholder representation from both sides. And we typically have both operational quality, HR, and also people considering the commercial aspects of the relationship, around those at least quarterly engagements.

In terms of KPIs, as we said, they need to reflect the key technical and operational deliverables, but also aspects of recruitment. So, time to recruit, staff turnover levels. But say within a QC analytical environment, we would also be looking at turnaround time, right-first-time measures relating to the QMS, be it deviations or CAPA, and also the review of the training matrix, a gap analysis, and remedial training or cross-training initiatives to address any gaps that are evident as part of that ongoing review. So, in summary, we wanted to consider a case study and take you through the engagement process and describe the key project deliverables and outcomes. So, there are three main stages that we've described. There's the engagement, where we discuss potential requirements. We develop that proposal.

We assess it from a compliance and a feasibility perspective and finalize that scope and contract with the client. Then we move into the delivery phase, where we're finalizing profiles and undertaking the recruitment activity and onboarding the resources, finalizing and implementing the KPIs, and doing a T-zero or initiation project kickoff meeting with all the key stakeholders involved to establish that governance process, which will be led by the client and the SGS team manager. And then when we get into steady state, it's an ongoing cadence of governance, where we're reviewing the project at an operational, a quality, and a commercial level on an ongoing basis. So as a result of that engagement process, this is an insourcing case study we wanted to describe to you, which involved a global pharmaceutical client that was establishing analytical QC activities to support new product development.

They required a team of QC analysts to perform activities relating to method development, release, and stability. Initially, quite a lot of method establishment and then moving into a more steady state of QC, release and stability study conduct. As part of the process, we provided candidate profiles and defined job descriptions with the client. We then were able to access our candidate pools and shortlist and interview candidates to onboard within 6-8 weeks. This was an initial team of 8, 8 FTEs, which was grown over the first year of the project to 40. The project is now in its fourth year of operation. Once selected, the FTEs were onboarded onto SGS payroll and employment contracts. Ongoing team performance is managed by SGS within the client's quality management and training environment.

SGS delivers performance and technical support to the insource teams. Regular governance and business review cadence, including KPIs, ensure that value is delivered to the pre-agreed service levels defined at the scoping phase of the project. Taking an insource managed service approach, where we share responsibility closely with the client for overall performance delivery, creates value. First of all, the team resource is onboarded in industry-best timeframes, leveraging the technology we have to access appropriate candidates against technical specifications quickly and with clear communication to the client. The administrative burden for the client is minimized, with only onboarding oversight and ongoing governance engagement required. Day-to-day execution management is the responsibility of SGS. Performance and continuous improvement framework was implemented within the SLA and ensures the ongoing maintenance and improvement of performance, but still maintaining flexible terms so that the team size can be flexed to meet changing demands.

We use our expertise to ensure that employment legislation is complied with and that we use our life sciences network infrastructure to provide offsite technical and development support for the team within our client's location. Well, we hope the presentation gave you an overview of the key elements required to expedite the implementation of insource teams into regulated environments within the biopharmaceutical and medical device industries. We're gonna follow now with a question-and-answer session. So please, I encourage you to submit any questions we have, and we'll endeavor to answer those in the remainder of the webinar, or later, we will reach out and make direct contact with you, if we don't get everything covered. But thank you again for your time, and we'll look forward to the upcoming Q&A. Thank you, everyone, for submitting the queries for Q&A.

I'm joined here with Samantha Bhattardeen, who heads up our global recruitment operations. So, just in response to the first question that we have relates to employment legislation. So the question, and I think, Sam, if you could pick this one up for me. But the question is, within Europe, are there differences in employment legislation related to temporary working contracts?

Samantha Bhattardeen
Head of Global Recruitment Operations, SGS

Yeah. Hi, everyone, and thanks, Mark. That's a really great question, and it's one that we're asked all the time. As the question implies, there are really wide variances in the employment legislation between countries. But because this is what we do day-to-day, we're very experienced with dealing with those challenges.

We have the support of the SGS local offices and experts alongside our in-house legal teams and any consultancy support we're required from companies like Deloitte, to be abreast of any employment or taxation contractual obligations. So that ensures that our solutions are always fully compliant.

Mark Glass
Head of Business Development EU, SGS

Great. Thanks. The next question again is one that's posed to us a lot, and it's really focused on how we collaborate, particularly at a supervisory level with our client. So, the question's actually, how do your supervisors collaborate with site client management on a day-to-day basis? That is managed through very clear definition in roles and responsibilities.

And the responsibility of the service provider, the insourcing service provider, is for performance management and delivery of the requirements of the service-level agreement, which includes the technical and HR aspects of the management of the team. Where we collaborate with the client, obviously working within their environment, their training and quality management system is from a facilitating perspective. So we can reach out and obviously collaborate on the resolution of technical issues and things like that. But in terms of the deliverables of the service-level agreement, that's the responsibility of SGS. So communication happens typically at a supervisory level and then is cascaded down to the team. But that's it. That's a good question. And I think we've got time for one more question.

It's, what, what role and, Sam, if you could take this one for me, what role, do the clients have in the interview and selection process?

Samantha Bhattardeen
Head of Global Recruitment Operations, SGS

Okay. It's an interesting question. As you mentioned in your presentation, Mark, all of our solutions are fully customizable and can be tailored to our client's needs. It's exactly the same for the hiring process. We're mindful of co-employment exposure, so we always factor that in. Our clients can be as involved or as hands-off as they choose to be. If the client just wants to see the CV of the person that we've selected, that's fine. If the client would like to conduct their own interview to assess team fit or technical ability once we've shortlisted a candidate, then that's fine too.

So to get the best out of our insourcing solution, we work really closely with our clients and always act as an extension of them anyway. So we'd like to think that we know what kind of talent makes our clients tick. But of course, there's nothing like the peace of mind you get from speaking to the new member of the team yourself. So yeah, we can be really flexible on that.

Mark Glass
Head of Business Development EU, SGS

Okay. Excellent. Okay. Well, with one eye on the clock, I'd just like to thank everybody for attending today. We do have a number of other questions, which we will reach out to you directly on after the webinar. So again, just thank you for affording us the time to join the webinar today. Thanks very much.

Samantha Bhattardeen
Head of Global Recruitment Operations, SGS

Thank you.

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