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PricewaterhouseCoopers (PwC)

Global professional services: assurance, tax, consulting

Digital Quality Consultant

Risk, Regulatory & Legal AdvisoryConfirmed live in the last 24 hours
Full-timeBrussels, BelgiumNo salary listed

About the Job

Requirements

  • At least 4 years of experience in pharmaceutical quality management, digital quality, quality consulting, or related roles, with demonstrable exposure to eQMS platforms, quality digitization, and/or quality analytics.
  • A Master's degree in Engineering, Pharmaceutical Sciences, a scientific discipline, or a related discipline.
  • Strong working knowledge of GxP regulations, including GMP, GDP, and GCP as relevant, and understanding of how digital systems support and evidence compliance.
  • Experience in at least one of eQMS implementation or migration, quality process design and automation, digital validation (CSA/CSV), quality data and analytics, or AI/ML applied to quality use cases.
  • Basic AI skills, including practical use of generative AI tools such as ChatGPT, Copilot, or Claude; prompt-engineering fundamentals; and understanding of AI/ML concepts such as large language models, classification, and anomaly detection and their applicability to quality use cases.
  • Understanding of digital quality concepts, including eQMS platforms, digital validation (CSA/CSV), data integrity (ALCOA+), process mining, quality analytics dashboards, robotic process automation in quality, and AI governance/GxP considerations for AI-enabled systems.
  • Strong communication, facilitation, and stakeholder-management skills for engaging global quality leaders and local affiliate teams.
  • Ability to write proposals and support business development.
  • Willingness to travel occasionally for client engagements, including affiliate and distribution site visits.

Responsibilities

  • Design, implement, digitize, and improve Quality Management Systems and end-to-end quality processes, including deviations, CAPA, change control, complaints, audits, supplier quality management, and management review.
  • Support and deliver digital quality management engagements for pharmaceutical and biotech clients, focusing on eQMS implementation and migration, quality process design and automation, and/or digital validation.
  • Lead and support eQMS selection and deployment activities, including Veeva Vault and TrackWise, requirement gathering, configuration workshops, and validation.
  • Apply AI and advanced analytics to quality operations, including deviation triage and classification, CAPA effectiveness, predictive quality, audit readiness, complaint trend analysis, and automated document review.
  • Advise clients on digital validation and compliance, including CSA/CSV, data integrity (ALCOA+), electronic records and signatures (Annex 11/21 CFR Part 11), and GxP considerations for AI-enabled systems.
  • Build quality analytics and performance-management capabilities, including KPI frameworks, quality dashboards, process mining, and data models connecting quality data across the value chain.
  • Support AI governance and responsible-AI frameworks for regulated environments, covering model lifecycle management, human oversight, explainability, and audit trails.
  • Work with cross-functional teams, including tax and technology colleagues, to deliver integrated end-to-end client solutions.
  • Translate quality process requirements into technology needs and support solution and vendor assessments.
  • Contribute to proposals, statements of work, and client-ready deliverables, ensuring quality, clarity, and consistency.
  • Take ownership of work, manage priorities, and deliver high-quality outputs meeting client expectations.
  • Apply practical experience in pharmaceutical quality, GDP, and affiliate quality to analyze client situations, identify risks, and propose pragmatic, compliant solutions.
  • Act as a trusted team member in client-facing settings, communicating with global quality leaders, local affiliate teams, and operational stakeholders.
  • Explore how eQMS, quality analytics, and generative AI can improve quality performance and efficiency.
  • Collaborate inclusively within diverse project teams, contributing to team culture while working autonomously and developing professionally.
  • Stay current with GDP regulatory developments, national variations, and emerging digital and AI trends in quality management.
  • Contribute to practice growth through business development, knowledge sharing, and thought-leadership initiatives.

Desired Qualifications

  • Experience gathering business requirements and working with IT, vendors, and system integrators in a regulated environment.
  • A background in consulting or advisory engagements.
  • Familiarity with digital tools supporting distribution quality, including track and trace, serialization, and IoT-based cold-chain monitoring.
  • Experience with agile delivery methods and tools such as Scrum, SAFe, and Jira in regulated environments.
  • Certifications in digital/AI domains, such as AI fundamentals, Microsoft/Google AI certifications, or Veeva Vault certifications.

About the Company

PricewaterhouseCoopers (PwC)

Global professional services: assurance, tax, consulting

PwC provides assurance (audit), tax, legal services, consulting and deals advisory to organisations worldwide. It uses multidisciplinary teams across accounting, advisory, technology and industry, delivered through a global network of locally established firms that collaborate with technology partners to offer AI, cloud, managed services and digital trust. PwC differentiates itself with an integrated, global-local service model and technology-enabled offerings that address complex client needs across risk, transformation, reporting and sustainability. Its goal is to help clients improve governance, efficiency and value by supporting reporting accuracy, business transformation, risk management and sustainable practices.

Company size
10,001+
Company stage
Early VC
Total funding
$3.3M
Headquarters
London, United Kingdom
Founded
1989

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