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Continuing our look at the people who make everything we do possible, this time we’re delving into the world of compliance, quality and safeguarding the supply chain on behalf of our customers and, ultimately, their patients.
With experience in community pharmacy and a degree in Pharmaceutical and Cosmetic Science, Nicole Lyons joined us in May 2020 as a Deputy Responsible Person. Six months ago, she was promoted to Responsible Person and also took on the Responsible Person (import) role. The Responsible Person is a statutory role, responsible for regulatory compliance of a business. The Responsible Person (import) is an additional role that was created to deal with post-Brexit legal changes.
Every day, Nicole’s efforts play an important role at critical points in our organisation.
A responsive way of working
”No day is the same in a business of this size and complexity. We deal with suppliers and customers with vastly different climates, geographies and time zones, so new queries and challenges can occur at any time. This means that as soon as I get to the office, I’m following up the most urgent queries which arose overnight – this could be anything from product recalls to logistical changes.”
After this, Nicole discusses outstanding issues with the wider regulatory team. She also works closely with commercial and finance teams, advising them on difficult or non-routine transactions.
“As a Responsible Person, there’s nothing more important than being responsive to the needs of my colleagues, other departments, and the wider business. It can be a challenge to balance the regulatory requirements in each territory with the practical and commercial needs of the business, but Smartway’s leadership team has proactively built a culture which ensures every decision is made with patient safety at the forefront. This makes my job easier.”
Mitigating risks in the supply chain
Throughout the day, Nicole spends a lot of her time finding solutions to difficult supply routes and territories.
“Our supply chain can be very complicated. Without careful monitoring and management, changes in transport routes or weather conditions can quickly affect product integrity. It’s my responsibility to make sure that this integrity is not compromised enroute to patients, no matter where in the world they’re based or where their medicines are sourced from.”
One recent example involved the purchase of a product from Italy, for supply to South America where a particular Active Pharmaceutical Ingredient (API) was in short supply.
For the regulatory team, this meant:
- mitigating various security and temperature risks which may impact the medicines during their transportation;
- ensuring the conditions of purchasing of the medicines were from an appropriate source country;
- liaising with commercial and warehouse teams to ensure each of the Bollinos were checked with UV light prior to dispatch on the most direct route available to the customer. A Bollino is a two-layer security label that is placed on pharmaceutical products in Italy.
After a lot of work, the shipment was successfully delivered last month – a prime example of how Smartway will always put in the extra effort to help our customers, even if we know it may only be a one-off transaction. It is recognised that at the end of the supply chain is a patient, who relies on us.
Nicole also closely monitors and analyses data in our electronic Quality Management System, or ‘’eQMS’’. This is a centralised platform that brings together data from across our operations, providing a single point of clarity and a detailed audit of our global operations. eQMS allows visibility over any pending changes or suggestions from anyone within Smartway, while reserving resource to be used only when it is needed.
As a Responsible Person, Nicole’s role depends on outstanding communication with people from across Smartway, as well as suppliers and other stakeholders – including regulators.
Every day, she undertakes a tour of the warehouse to check that the systems and processes in place are still working for all aspects of the business. This also maintains a high level of familiarity with our operations.
At the same time, she regularly liaises with the senior management team.
“I’m in regular discussion with the senior management team about new business ideas and plans. We’re proud to be continuing our expansion and growth – but this is always underpinned by our strong focus on quality and safety. Smartway’s senior leaders understand that expert regulatory advice is needed to make sure our high standards are upheld, no matter how we grow.”
Qualifying and working with suppliers and customers
Throughout the day, Nicole also determines risk ratings on new accounts. This involves liaising with regulatory authorities around the world to ensure that we are dealing with the right people. This means product quality is protected, while avoiding undue delay or disruption to supply.
“As a distributor, it’s our responsibility to understand the entire supply chain – where medicinal products are coming from, where they’re going, and how they get there safely.”
Driving Continuous Improvement
Finally, Nicole takes part in a management review meeting once a week. This is an opportunity to review any trends and improvement opportunities within Smartway, using data collected in eQMS, business intelligence and internal observations. It’s also where new starters are discussed to ensure training plans are sufficient and on track for completion.
“Our management reviews are really vital to making sure each department is on the same page. It’s a way to make sure we’re not just responding to what every day brings, but also thinking strategically about our compliance and how we can improve.”
We’re always recruiting
If you share our commitment to quality, preserving quality and going further for our customers, send your CV to [email protected].
