Job description
As Quality Assurance (QA) & Computer System Validation (CSV) Lead, you will ensure quality, compliance and validation excellence throughout the implementation lifecycle while working with multidisciplinary teams across Digital, Manufacturing, Engineering, Automation and Quality.
Your missions
- Lead all QA & CSV activities for the NGM PAS|X implementation program.
- Define and maintain a risk-based validation strategy for PAS|X, infrastructure, interfaces and GxP systems.
- Ensure compliance with GxP, GAMP 5, EU GMP Annex 11, 21 CFR Part 11 and Data Integrity across the lifecycle.
- Provide QA oversight from design and testing through deployment, go-live and handover.
- Review and approve key validation documents (plans, specs, risk assessments, traceability, tests, reports, changes, deviations, CAPAs).
- Act as the primary QA-CSV authority in project governance and support deployment & inspection readiness.
- Embed Data Integrity into design, validation activities, security controls, audit trails and electronic records.
- Prepare the project for audits and regulatory inspections.
- Collaborate with Global NGM, Digital/IT, Automation, Engineering, Manufacturing and QA.
- Mentor project teams on CSV best practices, quality risk management and regulatory expectations.
Your profile
- Bachelor’s or Master’s in Engineering, Computer Science, Life Sciences, Biotechnology, Pharmacy or related.
- 8+ years in Computer System Validation in pharma/biotech/medtech.
- 5+ years in a lead QA-CSV / validation governance role on complex GxP projects.
- Strong experience with MES, automation interfaces and digital manufacturing.
- Excellent knowledge of GAMP 5, EU GMP Annex 11, 21 CFR Part 11 and Data Integrity.
- Solid understanding of computerized system lifecycle from project to operations.
- Hands-on with validation documentation, change control, deviations, CAPAs and risk assessments.
- Experience with PAS|X or similar MES (e.g. Syncade, PharmaSuite) is a strong plus.
- Experience supporting regulatory inspections and compliance audits.
- Strong stakeholder management, leadership and communication in international, cross-functional environments.
- Analytical mindset with sound quality decision-making in complex deployment programs.
- Fluent in English; French and/or Dutch is a plus.
What we offer
Joining Amaris isn’t about joining a company where you simply wait patiently for a vacancy to arise. It’s about becoming part of an environment where your performance directly drives your career progression.
In practical terms, here’s what this means for you on a daily basis:
Projects worth your time 18+ months on average, with major accounts (Orange, Sanofi, SNCF, CMA-CGM…) and the support of our internal Centers of Excellence. You get the depth, not just the breadth.
Real management support 1 manager for up to 18 consultants, structured project check-ins, and a direct line to HR every month through Express Yourself. Our teams average 3.3 years of tenure — proof that we build something that lasts.
A career that actually moves 70% of our managers started at entry level. Average age: 36. Here, trust comes before experience and merit drives progression — not seniority. Functional (4 areas of expertise) and geographic (60+ countries) mobility are actively encouraged.
Innovation, in practice 291 AI agents built in-house, 250+ training modules, Microsoft certifications fully funded. At Mantu, AI stands for Artificial Intelligence — and Augmented Impact.
CSR with real targets SBTi carbon reduction roadmap, 32% women in management (target: 34.3% by 2029), social engagement through We Care Together.
Health insurance, remote work, meal vouchers, time savings account, referral bonus… Find the full benefits breakdown at our dedicated page.
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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Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!