Line of Service
Advisory
Industry/Sector
Not Applicable
Specialism
Advisory - Other
Management Level
Senior Associate
Job Description & Summary
About PwC
At PwC, our purpose is to build trust in society and solve important problems. We work with leading organisations to create meaningful impact, combining deep industry expertise, technology and human insight. In Belgium, we foster an inclusive, respectful and growth-oriented culture where people are encouraged to learn continuously, take ownership and collaborate across borders and disciplines. You will join a fast-paced and high-impact environment where your work contributes directly to better healthcare outcomes for patients and society.
About the Health Industries, R and D and Quality team
Our Health Industries, R & D and Quality team supports pharmaceutical, biotech and life sciences organisations in strengthening and transforming their quality operations across the end-to-end value chain. We help clients design, implement and optimise fit-for-purpose Quality Management Systems, operating at the intersection of regulation, strategy, operations and digital innovation.
What your day will look like
As a Quality Management Professional, you will take an active role in client engagements, working autonomously on well-defined workstreams while collaborating closely with colleagues and clients across Europe and beyond. Your day-to-day activities will include:
- Designing, implementing and improving Quality Management Systems and end-to-end quality processes such as deviations, CAPA, change control, complaints, audits, supplier quality management and management review.
- Supporting and delivering quality management engagements for pharmaceutical and biotech clients, with a focus on GDP compliance, affiliate quality oversight, distribution and warehousing operations, and Responsible Person related activities.
- Contributing to the setup and maturation of affiliate quality frameworks, including local QMS deployment, alignment with local regulations, and global-to-local quality governance models.
- Advising clients on GDP-compliant distribution and warehousing quality, including temperature-controlled logistics, cold-chain management, transport and warehouse qualification, serialization and last-mile distribution quality.
- Supporting digital quality initiatives such as eQMS implementations, QMS migrations and the digitisation of quality processes.
- Applying AI and advanced analytics concepts to quality operations, for example in deviation triage, CAPA effectiveness, predictive quality, audit readiness and complaint trend analysis.
- Working with cross-functional teams, including tax and technology colleagues, to deliver integrated and end-to-end solutions for clients.
- Translating quality process requirements into clear technology needs and supporting solution and vendor assessments.
- Contributing to proposals, statements of work and client-ready deliverables, ensuring high quality, clarity and consistency.
Qualifications
- Minimum 4 years of experience in pharmaceutical quality management, quality consulting, or related roles, with demonstrable exposure to GDP, affiliate quality, and/or distribution & warehousing quality .
- Master’s degree in Engineering, Pharmaceutical Sciences, a Scientific Degree, or a related discipline.
- Strong working knowledge of GxP regulations, with deep expertise in GDP (EU GDP Guidelines, WHO GDP), and good understanding of GMP interfaces at the manufacturing-to-distribution handover.
- Experience in at least one of the following areas: affiliate/local market quality, distribution & warehousing quality, 3PL/wholesaler oversight, QMS implementations , or quality process design.
- Experience working with or supporting Responsible Persons (RPs) and local affiliate quality organizations is a strong plus.
- Background in consulting or advisory engagements is a plus.
Digital & AI Skills (Required Profile)
- High affinity for digital and AI , with genuine curiosity and drive to apply these technologies to quality challenges.
- Basic AI skills : practical experience using GenAI tools (e.g., ChatGPT, Copilot, Claude) for productivity, prompt engineering fundamentals, and understanding of core AI/ML concepts (LLMs, classification, anomaly detection) and their applicability to quality use cases.
- Good understanding of digital quality concepts : eQMS platforms, digital validation (CSA/CSV), data integrity (ALCOA+), process mining, quality analytics dashboards, RPA in quality, and AI governance / GxP considerations for AI-enabled systems.
- Familiarity with digital tools supporting distribution quality (track & trace, serialization, IoT-based cold-chain monitoring) is a plus.
Skills
- Strong communication, facilitation, and stakeholder-management skills, including the ability to engage with global quality leaders and local affiliate teams.
- Ability to write compelling proposals and support business development.
- Willingness to travel occasionally for client engagements, including affiliate and distribution site visits.
Nice to Have
- Responsible Person (RP) qualification under EU GDP Guidelines (or equivalent national qualification).
- Qualified Person (QP) certification under Directive 2001/83/EC / 2001/82/EC (Annex 16 of EU GMP).
- Hands-on experience acting as RP, Deputy RP, or QP within a pharmaceutical wholesaler, distributor, or MAH organization.
- Certifications in digital/AI domains (e.g., AI fundamentals, Microsoft/Google AI certifications, Veeva Vault certifications).
What we will expect from you
At PwC, Professionals are expected to combine strong technical foundations with ownership, collaboration and a continuous learning mindset. In this role, we expect you to:
- Take ownership of your work, manage priorities effectively and deliver high-quality outputs that meet client expectations in a dynamic and challenging environment.
- Apply your practical experience in pharmaceutical quality, GDP and affiliate quality to analyse client situations, identify risks and propose pragmatic, compliant solutions.
- Act as a trusted team member in client-facing settings, communicating clearly and professionally with global quality leaders, local affiliate teams and operational stakeholders.
- Demonstrate a strong affinity for digital and AI-enabled ways of working, actively exploring how technologies such as eQMS, quality analytics and GenAI can improve quality performance and efficiency.
- Work collaboratively and inclusively within diverse project teams, contributing to a supportive team culture while also showing autonomy and ambition in your personal development.
- Continuously develop your expertise by staying up to date with GDP regulatory developments, national variations and emerging digital and AI trends in quality management.
- Contribute to the growth of the practice by supporting business development, knowledge sharing and thought leadership initiatives.
What you can expect from us
At PwC Belgium, we invest in your growth, wellbeing and long-term career. You can expect:
- A collaborative and inclusive work environment where diversity, respect and equal opportunities are fundamental.
- Continuous learning and development through structured training, on-the-job learning, coaching and exposure to a wide range of clients and projects.
- Opportunities to develop both technical expertise in quality, GDP and digital transformation, and essential consulting skills such as stakeholder management and problem solving.
- Flexible working arrangements that support a healthy work-life balance and recognise individual needs.
- Competitive compensation and benefits in line with the Belgian market, including wellbeing initiatives and mobility options.
- The opportunity to work on meaningful projects that contribute to safer, more efficient and more resilient healthcare supply chains.
Final words about PwC
Joining PwC means becoming part of a global network of professionals who are passionate about making a difference. If you are motivated by quality, innovation and purpose-driven work, and you want to grow in a challenging yet supportive environment, we would be delighted to hear from you. At PwC Belgium, your ideas, your curiosity and your ambition truly matter.
Education (if blank, degree and/or field of study not specified)
Degrees/Field of Study required:
Degrees/Field of Study preferred:
Certifications (if blank, certifications not specified)
Required Skills
Quality, Cost, Delivery (QCD), Quality Analysis, Quality Management, Quality Performance
Optional Skills
Accepting Feedback, Accepting Feedback, Active Listening, Analytical Thinking, Business Data Analytics, Business Performance Metrics, Business Transformation, Change Management, Communication, Creativity, Embracing Change, Emotional Regulation, Empathy, Epic Software, Epic Systems, Inclusion, Intellectual Curiosity, Learning Agility, Logistics Management, Management Consulting, Manufacturing Operations Management, Market Research, Operating Effectiveness Review, Operational Excellence, Operational Performance Management (OPM) {+ 18 more}
Desired Languages (If blank, desired languages not specified)
Travel Requirements
Not Specified
Available for Work Visa Sponsorship?
No
Government Clearance Required?
No
Job Posting End Date
