Job Description

Location

Dublin, hybrid (home-based with office attendance, approx. 1 day per month, for physical document control activities)

Eligibility to work

Unfortunately we cannot offer Irish work permits or Visa sponsorship.

The opportunity

We're looking for a Quality Associate to own document control and training administration across the business and to help us get the most out of a brand new quality management system.

We are implementing Greenlight Guru, a modern, AI-enabled, highly configurable eQMS. You'll be one of the first people to learn it inside out, and you'll have real scope to shape how workflows are configured to suit how Deciphex actually works. This isn't a role where you inherit a fixed process and follow it, you'll be trusted to improve it.

You'll also sit at the centre of the business. Requests come in from every team, pre-clinical, clinical, software, AI, so you'll get exposure to some genuinely interesting technology simply by supporting the people building it.

What you'll do

• Own the electronic document control process, the document register, the document control mailbox, and the document library structure
• Administer the eQMS (Greenlight Guru): become the in-house expert on its functions and workflows, and train colleagues on how to use it
• Manage the training system, onboarding and offboarding, assigning and tracking training, chasing outstanding records, and keeping training files complete
• Run the process for creating new controlled documents and for periodic document review
• Prepare and review controlled documents for formatting and accuracy, and process GxP documents for e-signature
• Manage physical documentation in the Dublin office, receiving, filing and archiving records, including materials sent from our other sites
• Support customer and regulatory audits, gathering and presenting documentation, acting as scribe or runner, and assisting the QA host
• Maintain the supplier register and keep supplier certification current
• Record and report KPIs for document control, training and other quality processes
• Provide back-up support on CAPA, deviation and change management
• Support Deciphex sites in the UK, US and elsewhere as needed

What we're looking for

• A qualification (certificate, diploma or degree) in a life science, IT or related discipline
• 2+ years' experience in a document control, training administration, QA or quality systems role within a regulated life science environment (pharma, medical device, IVD, CRO or similar)
• Hands-on experience administering an electronic quality or document management system — this matters more to us than the number of years on your CV
• Adaptability. No two days look the same here. You'll open your inbox, see what's landed, and reprioritise around it
• Strong communication and relationship-building. You'll deal with people across every part of the business. We want someone approachable, who listens, who people are glad to hear from — not a gatekeeper
• The ability to organise and prioritise your own workload with support, rather than direction
• Diligence and attention to detail when reviewing documents

Nice to have: experience delivering training; exposure to GLP, ISO 13485 or ISO 9001; experience supporting customer audits; experience with Greenlight Guru or a comparable eQMS.

About the Company

Through the work that we do, the team at Deciphex helps pharma to accelerate the process of essential drug development and helps patients to get timely and accurate diagnosis.

Founded in Dublin in 2017, Deciphex has scaled rapidly to a team of over 230 people and counting who are providing software solutions to address the pathology gap in research pathology and clinical areas. We have offices in Dublin, Exeter, Oxford, Toronto and Chicago and are expanding our team throughout the world.

We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients. Our team culture is built on trust. We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it.

We are looking for highly motivated individuals who are excited to take on challenges and value making a difference in their day-to-day work. This is a unique opportunity to make a difference in the emerging Digital Pathology field.

Read more about Deciphex here and more about our incredible team on our Careers Page here

What are the benefits of working with Deciphex?

• Healthcare benefits
• Competitive annual leave
• A true sense of meaning in your work by contributing to better patient outcomes.
• The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment.
• A chance to work on exciting,challenging and unique projects.
• Regular performance feedback and significant career growth opportunities.
• A highly collaborative and supportive multi cultural team.

Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law.

A copy of our Privacy Policy can be viewed here