Job description
Position Overview
Lead the quality assurance for clinical trial materials and companion diagnostics (CDx) in a fast-growing GMP environment. Drive compliance across EU regulations while building and mentoring a high-performing QA team.
Key Responsibilities:
Quality Leadership & Compliance
- Implement and maintain QMS compliant with EU GMP, FDA, and ICH guidelines
- Serve as regulatory authority for batch release decisions (IMP, CDx products)
- Lead QP oversight for UK clinical trial material releases
- Drive continuous improvement through risk-based quality systems
Team Management:
- Supervise 5-8 QA specialists across pharmaceutical and CDx verticals
- Own recruitment, training, and performance development for your team
- Set departmental KPIs aligned with global quality objectives
Technical Oversight
- Approve CAPA, change controls, and validation protocols for:
- Pharmaceutical manufacturing processes
- CDx IVD device development and manufacturing
- Equipment/utility qualification (IQ/OQ/PQ)
- Lead design verification/validation for CDx products
- Manage vendor qualification and audit programs
Regulatory Interface:
- Host regulatory inspections (EMA, FDA, client audits)
- Lead internal audit program (schedule, execute, follow-up)
- Ensure post-market surveillance compliance for CDx devices
Required Qualifications:
- Bachelor's in Life Sciences, Pharmacy, or Engineering
- 7+ years GMP QA experience in pharma/medical device manufacturing
- Proven team leadership experience (minimum 3 direct reports)
- Expertise in CAPA, change control, and deviation management
- Fluent in English and Dutch is mandatory (business proficiency required)
Preferred Qualifications:
- Master's/PhD in relevant field
- QP eligibility or certification
- Lead Auditor certification (ISO 13485, GMP)
- Black Belt/Six Sigma certification
- Experience with lab establishment in GMP environment
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
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.
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!