Name | Orlaith Greenan
Role | Sr. Director, Quality and Compliance
Joined | October 2023
Academic background | BSc (Hons) Genetics and Cell Biology
The quality bug hit me early and unexpectedly. Whilst studying for my undergrad, I was offered a 6-month industrial placement which appointed me to a role within the quality team for drug substance development within a large pharmaceutical organisation outside Dublin. I was… devastated. My dreams of donning a white coat and saving the world were dashed… but not for long!
I was quickly captivated by the variety in the role. I had the honour of seeing processes from start to finish, working cross-functionally, and, of course, my inner sleuth was unleashed when I discovered root-cause investigations!
I relished helping myself and my peers to continually improve and become more efficient, one step at a time.
After moving to the UK in 2011, I continued my quality career, holding management and leadership roles within QC release laboratories, genomic laboratories and later on, at an integrated CRO/CDMO where I led the Clinical QA team, prior to developing and leading the global quality team.
I joined bit.bio in October 2023 leading the quality & compliance function and I’m honoured to have joined such an aspirational company and exceptional team.
Internally, the most rewarding part of the role is facilitating improvement and efficiency projects. Sometimes the perception of compliance-related functions is that they create additional work. If done right, however, quality is really all about understanding what is important and building frameworks to drive the consistent and transparent execution of those important elements. This, in turn, makes us more efficient by applying effort commensurate with risk - and spending less time on non-value-added work.
I love seeing quality improvement programmes make life easier for my peers, increase ‘right first time’, and help guarantee the satisfaction of the requirements necessary for the company to maintain and scale operations.
Externally, it’s hard not to feel like you are a part of something BIG at bit.bio. It’s incredibly rewarding to be part of a team driving ground-breaking science and working to change the future of healthcare.
Quality and compliance complement innovation. It does, however, require somewhat of a longer-term view.
Think about it…
The ultimate goal of quality is consistency and reproducibility. If we control what matters, we can better predict outcomes, we can monitor effectiveness, and if things go wrong, we seek the answers quickly, to ensure we correct the issues only once.
Ultimately this means we are successful in our objectives more frequently, limiting the amount of time spent on repeat or non-value-added work.
The key here is to work with our functional colleagues to agree and understand where to apply the controls and to ensure we remain efficient by applying these controls in a way that is commensurate with risk and value.
Compliance also serves to help guarantee our strategic success, by focusing on building and maintaining systems and processes designed to keep our patients safe, our customers happy and our approvals and licences in place.
It’s an exciting time for quality and compliance as there is an explosion of very cool and intelligent electronic systems to take the hassle out of compliance - ensuring less time is spent on wasteful administration work.
bit.bio has partnered with Veeva Systems for our document, content and training solution and we are excited to be embedding this throughout 2024 and beyond.
Veeva are a truly innovative company and AI is at the forefront of their strategy, whether that’s building in functional-level AI to reduce the burden of high-volume repetitive tasks (for example document classifications or recurrence assessments: have we had this type of product complaint before?) or by taking advantage of large language models to enable us to interrogate the information to glean real knowledge.
My QA career started with reams and reams of paper, lever-arch folders, Access databases and Excel spreadsheets so this is a very welcome change to the landscape
I learned one of my biggest life lessons rather early in my career and it’s a fundamental component of my approach to work and life in general.
Whilst working as a senior auditor, my place of work was hit by a major disaster. The kind of event that underlines emboldens and puts exclamation marks on the importance of having a BCDR (Business Continuity, Disaster Recovery) Plan.
Then, due to an unexpected change in the team, I was thrust into a leadership role.
What followed was a colossal task of maintaining business as usual for customers, preventing bottlenecks in the pharmaceutical product supply chain, validating temporary facilities, and rebuilding for the future. All the while, ensuring that our customers, accreditation bodies and regulatory authorities were satisfied that our planning and execution met the GxP needs of quality, safety and data integrity.
This experience was character-building, to say the least, and from it, I learned the following:
No person is an island. Open and collaborative working with peers is fundamental to ensuring strategies, plans and decisions are as well-rounded and as considered as possible.
This opens up the ability to understand, better manage and mitigate risk, ensuring that work is as efficient and effective as possible.
The focus of my role is far-reaching. It’s important to maintain a balance between developing and building a quality management system (QMS) that supports bit.bio and its people, whilst also maintaining “business as usual” for the role of quality in research products and our therapeutics programmes. Key to this success is building and maintaining relationships with my team(s), stakeholders and colleagues, so you could say there can be multiple plates spinning at any given time.
I am human so I can’t operate at 100% capacity 100% of the time. I am, however, a firm believer in “creative flow” so when the flow hits, I go with it. I’m lucky to have a flexible lifestyle and a (very) understanding husband which gives me the freedom to work the unusual hours that this may require.
When I’m not feeling particularly creative, I focus more on transactional tasks.
Finally, if stuck, I lean on my peers. Sometimes, speaking on a topic enables you to onboard new ideas, and kick-start “the flow”.
I am a true foodie. My husband and I love experimenting with new recipes. We socialise with friends and family, either around a dinner table, or out at pubs/restaurants. Food and drink are a real passion.
Orlaith with her family in the UK countryside walk.
Additionally, we love walking in the UK countryside and taking advantage of the wonderful ‘right of way’ laws often taken for granted. Even growing up in Ireland, I didn’t have the same access to the countryside as I do here.
Orlaith's cute cat on the walk with her.
I also like to spend my quiet time chilling with my cats, reading or practising piano (and believe me, I need a lot of practice).
Every interaction we have with a person can be clouded by noise (noise can be due to previous interactions or experience with the person, or others, on the topic, or other life/social distractions), so how a message is intended may not equal how it is perceived.
To ensure a greater chance of aligning on intention and perception, trust is key. Trust helps clear the noise, to ensure that good intention is the default perception.
So, my philosophy is that it takes one negative experience to break a trust, and a thousand positive experiences to re-build it.
Vibrant, energetic, collaborative and friendly.
It’s not only an aesthetically pleasing environment full of colour and plants, but the hot-desking system also allows you to either book seats in advance, or ‘trust’ the random allocation. I favour random allocation, so I can interact with others and build relationships. There is no end to friendly faces and conversation at bit.bio.
bit.bio puts a significant effort into ensuring we not only recruit the brightest talent but that we prioritise cultural fit. Diversity is important at bit.bio but what we all have in common is passion, open-mindedness and a collaborative nature.