Management Review Lead
Mission.
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The mission consists of transforming and modernizing the GMP/GDP Management Review process within a pharmaceutical environment, evolving it from a primarily compliance\-driven and retrospective exercise into a forward\-looking, proactive, and insight\-driven governance framework.
The role focuses on strengthening Quality Management System (QMS) governance, improving visibility on quality system performance, and enhancing the connection between operational quality indicators, patient safety, portfolio risks, and enterprise decision\-making.
Beyond GMP/GDP activities, the objective is to support a broader Quality Transformation program, with future expansion across additional domains such as Clinical, R\&D, Development, and Pharmacovigilance.
The goal is to enable the organization to improve quality governance maturity, strengthen strategic oversight, and support data\-driven quality decision\-making across the enterprise.
Key Responsibilities
- Quality Governance \& Management Review Transformation
- Quality Management System (QMS) Optimization
- Stakeholder Management \& Cross\-Functional Collaboration
- Benchmarking \& Best Practices
- Data Analysis \& Governance Insights
- Transformation Delivery \& Operational Implementation
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Required Expertise – Quality Governance / QMS Transformation Consultant
- Pharmaceutical Quality Management Systems (QMS) (Expert, current experience)
- GMP/GDP governance and Management Review processes (Expert, current experience)
- Quality transformation and governance frameworks (Advanced, current experience)
- Stakeholder management and cross\-functional collaboration (Advanced, current experience)
- Strategic\-to\-operational implementation capabilities (Advanced, current experience)
- Data interpretation and governance reporting (Advanced, current experience)
Experience
- Minimum 5–8 years of relevant experience in pharmaceutical quality governance or QMS environments
- Proven experience operating autonomously within complex quality transformation initiatives
- Experience balancing strategic governance design and operational implementation
Strong expertise in:
- Pharmaceutical QMS
- GMP / GDP processes
- Management Review governance:
- Ability to work independently with minimal supervision
- Strong analytical capabilities with the ability to interpret
- Trends
- Performance indicators
- Governance risks
- Strong stakeholder communication and influencing skills
- Experience with benchmarking and governance maturity assessments
- Familiarity with quality governance frameworks
- Conceptual understanding of Qlik and/or Power BI environments
- French language skills are considered an asset
Languages
- English – Fluent (mandatory)
- French – Nice to have
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