Senior Associate Quality Management
Il y a 7 jours
Brussels, Brussels, Belgique
PwC
Temps plein
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Line of ServiceAdvisoryIndustry/SectorNot ApplicableSpecialismAdvisory
- OtherManagement LevelManagerJob Description & SummaryAbout PwCAt 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 teamOur 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 likeAs 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.
QualificationsMinimum 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.
SkillsStrong 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 HaveRes
- OtherManagement LevelManagerJob Description & SummaryAbout PwCAt 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 teamOur 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 likeAs 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.
QualificationsMinimum 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.
SkillsStrong 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 HaveRes