Position Overview
We are seeking an experienced Management Review Lead to drive and evolve the Management Review process into a forward-looking, insight-driven governance mechanism that connects quality system performance with patient safety, portfolio risk, and strategic decision-making.
This role plays a critical part in ensuring leadership has a predictive and actionable understanding of quality health across the organization, enabling proactive risk management and continuous improvement of the Pharmaceutical Quality System throughout the product lifecycle.
The successful candidate will help transform Management Review from a retrospective reporting exercise into a strategic process focused on anticipating risks, enabling informed decisions, and improving patient outcomes.
Experience Level
* Senior-level professional
* 7–10 years of relevant experience preferred
Enterprise Management Review Strategy & Execution
* Lead and continuously improve the end-to-end Management Review framework across global, functional, and site-level operations
* Critically review reports and outputs generated through the Management Review process
* Ensure governance structures align with ICH Q10 requirements while focusing on decision quality and effectiveness beyond baseline compliance
* Drive consistency, transparency, and simplification across management review forums and governance processes
Quality Insights & Risk Visibility
* Translate complex Quality Management System (QMS) data into meaningful executive insights and strategic recommendations
* Analyze and communicate:
o Leading and lagging quality indicators
o Cross-functional and cross-portfolio risks
o Emerging trends impacting patient safety and supply continuity
* Collaborate with Quality Intelligence and data teams to enhance reporting, visualization, and data quality capabilities
Executive Decision Support
* Serve as a trusted advisor to senior leadership on:
o Quality risk prioritization
o Organizational capability and resource needs
o Compliance and patient-impact trade-offs
* Ensure management decisions are actionable, traceable, and effectively followed through
* Facilitate data-driven decision-making within quality governance processes
Continuous Improvement & System Maturity
* Assess and strengthen the maturity of Management Review practices using internal learnings and industry benchmarks
* Integrate lessons learned from inspections, recalls, audits, and external quality events into governance processes
* Promote a culture of continuous improvement and operational excellence within the Pharmaceutical Quality System
Regulatory & Inspection Readiness
* Position Management Review as a demonstration of quality culture and proactive governance, not solely a compliance requirement
* Act as a global Subject Matter Expert (SME) during inspections, audits, and interactions with health authorities
* Support regulatory readiness initiatives and ensure governance practices meet evolving industry expectations
Required Qualifications
Education
* Bachelor’s or Master’s degree in:
o Life Sciences
o Pharmacy
o Engineering
o Quality Management
o Or another relevant scientific or technical discipline
Experience
* 7–10 years of experience in the pharmaceutical or biotech industry
* Strong background in Pharmaceutical Quality Systems (QMS) and quality governance
* Proven experience supporting or leading Management Review processes in GMP-regulated environments
* Experience working with senior leadership and cross-functional stakeholders
* Fluency in French is mandatory
Required Skills & Competencies
* Deep expertise in pharmaceutical quality systems, governance, and quality risk management
* Strong understanding of Management Review processes and operational execution, including:
o Data preparation
o Documentation management
o Meeting coordination
o Action tracking
o Strategic mindset with strong executive communication and presentation skills
o Ability to synthesize complex data and trends into actionable business intelligence
o Strong stakeholder management and influencing capabilities across all organizational levels
o Excellent analytical and problem-solving skills
o Passion for patient-centric quality decision-making and continuous improvement
o Ability to work effectively in complex, matrixed organizations
Benefits
o Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
o Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
o International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
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