Makes Quality simpler and release faster by giving Operations one global Quality system and, through Smart Release, a path towards risk-based, AI-supported review by exception over time.

The role owns the global Quality Management System (QMS), Complaints and Training governance within the Rare Disease Unit (RDU), setting one global standard for each process so that every team and site works the same way and learns from the same evidence. It is the business owner of Smart Release, accountable for its vision, roadmap, adoption and benefits.

Locations - Dublin, Athlone or Cork, Ireland

Key accountabilities

Lead Smart Release so that release moves, over time, towards review by exception

• Own the Smart Release vision, target process, roadmap, business case and benefits, as part of the integrated Future Quality 2030 transformation roadmap.

• Translate customer and Quality Operations needs into prioritised process, data, technology and control requirements, and lead redesign and adoption with the teams affected. Each team leader stays accountable for compliant execution in their own area.

• Track benefits such as release cycle time, right-first-time, exception resolution, capacity and supply reliability, and prioritise further simplification and automation by risk and value.

• Own and continuously improve the operating model of QMS + Smart Release.

Give Quality Operations one simple global QMS

• Own the global QMS for the Rare Disease Unit and its core processes: deviations and quality events, corrective and preventive action (CAPA), change control, documentation, training, SAP Quality inputs, complaints and Quality Risk Management; lead Quality Management Review, lead Annual Product Quality Review (APQR), which each site carries out against global requirements.

• Set one global standard for each process, with clear process owners, local responsibilities and escalation routes; simplify and harmonise processes across the network, and lead the Digital QMS programme so Quality workflows become simpler and digital for every team.

• Advance Quality Management Maturity in line with ICH Q10, and modernise Quality Risk Management in line with ICH Q9(R1) so that risk, evidence and decisions are clearly linked.

• Build knowledge management and leading indicators so that lessons are captured, reused and acted on earlier.

AI compliance in QMS

• Redesign work so that, over time, AI takes on evidence gathering, classification and routing, and experts spend their time on judgement.

• Work with Quality Data, Digital & AI Assurance, which independently assures data, systems and AI for their intended use.

Lead a capable, inspection-ready global team

• Feed Quality system and release performance into the function-wide view of performance.

• Lead inspection and audit support for QMS and Smart Release; escalate systemic Quality risks and drive timely, effective closure of commitments.

• Apply data-integrity requirements to the data QMS, Complaints and release processes create.

• Lead and develop a global team of Quality Systems professionals and process owners, with strong succession, new skills for AI-enabled work and a culture of continuous improvement.

You will need to have:

Degree in pharmacy, science, engineering or a related discipline; advanced degree preferred

Extensive senior Quality leadership in a global, highly regulated biopharmaceutical setting

Proven leadership of global Quality Systems and Complaints, including regulatory inspections

Led a comparable shift: global process simplification or release redesign through a matrix

Technical expertise in QMS, complaints, risk management, CAPA, change control and data integrity, end-to-end disposition and release across manufacturing, testing and external supply

Enough data and AI fluency to shape use cases and challenge AI outputs

Date Posted

Closing Date