Quality Workstream Lead

Valtera Group Ltd; Dublin; On-site; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Fully remote worldwide

Job summary

Valtera Group Ltd is seeking a Quality Workstream Lead to own digital solutions across LIMS, Quality Systems and AI enablement in a fully remote, globally distributed manufacturing and laboratory network.

You will drive deployment, adoption and continuous improvement, coordinating across Quality, QC Laboratories, Manufacturing IT and Validation to deliver measurable productivity, compliance and operational gains.

Qualifications

• 12+ years in pharma/regulated manufacturing environments.
• Strong understanding of Quality and QC Laboratory operations.
• LIMS implementation experience.
• Experience with eQMS, CAPA, deviation management or document control.
• Experience leading large-scale workstreams or multi-site transformation programmes.
• Knowledge of GxP, CSV/CSA, Data Integrity and ALCOA+ requirements.
• Experience with AI, analytics, automation, Lean or Six Sigma is highly desirable.

Responsibilities

• Lead the Quality and Laboratory workstream for a global LIMS programme.
• Drive business value realization, KPI tracking and process improvement initiatives.
• Support requirements gathering, testing, validation, training, go-live and hypercare activities.
• Partner with Quality, Manufacturing, IT, Data Science and Validation stakeholders globally.
• Standardize laboratory and Quality processes across multiple sites.
• Identify opportunities for analytics, automation and AI within Quality operations.
• Develop business cases and ensure benefits are realized post-implementation.

Skills

LIMS deployment

Quality systems

GxP & Data Integrity

ALCOA+

AI & Automation

Multi-site programs

Lean Six Sigma

Tools

LIMS

eQMS

CAPA

Document control

Job description

Quality Workstream Lead – LIMS, Quality Systems & AI Enablement

Fully Remote | Global Manufacturing Network

We're supporting a global pharmaceutical organisation undergoing a large-scale digital transformation across its manufacturing and laboratory network.

As Quality Workstream Lead, you'll act as the business owner for Quality and Laboratory digital solutions, leading the deployment, adoption and continuous improvement of LIMS, Quality Systems and AI-enabled technologies. Working across Quality, QC Laboratories, Manufacturing, IT and Validation teams, you'll ensure new solutions deliver measurable improvements in productivity, compliance and operational performance.

What You Will Do

• Lead the Quality and Laboratory workstream for a global LIMS programme.
• Drive business value realization, KPI tracking and process improvement initiatives.
• Support requirements gathering, testing, validation, training, go-live and hypercare activities.
• Partner with Quality, Manufacturing, IT, Data Science and Validation stakeholders globally.
• Standardize laboratory and Quality processes across multiple sites. ]
• Identify opportunities for analytics, automation and AI within Quality operations.
• Develop business cases and ensure benefits are realized post-implementation.

What We're Looking For

• 12+ years' experience within pharmaceutical, biotech or regulated manufacturing environments.
• Strong understanding of Quality and QC Laboratory operations.
• Significant LIMS implementation or deployment experience.
• Experience with Quality Systems including eQMS, CAPA, deviation management or document control.
• Experience leading large-scale workstreams or multi-site transformation programmes.
• Strong knowledge of GxP, CSV/CSA, Data Integrity and ALCOA+ requirements.
• Proven ability to deliver measurable operational and business improvements through digital transformation initiatives.
• Experience with AI, analytics, automation, Lean or Six Sigma is highly desirable.