Job description
Job Purpose
Within the External Manufacturing you will support Contract Manufacturing Operations (CMO) by overseeing key quality activities. Your role focuses on GMP compliance, governance, and continuous improvement, rather than hands-on technical/operational activities.
You will ensure that products manufactured by CMOs comply with cGMP, regulatory requirements, and internal quality standards, while driving lean management and process optimization.
Main Responsibilities
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CMO Quality Oversight & Governance
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Take accountability for main quality activities related to CMO management
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Review and follow up on deviations, ensuring appropriate investigation and documentation
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Monitor and support CAPA implementation and timely closure
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Manage and assess change controls linked to CMOs and their impact on product quality
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Help put in place and maintain governance for quality processes and interactions with CMOs
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Batch Release & Complaints
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Provide support for product batch release activities (documentation review, quality decision support)
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Ensure the review and approval of product market complaints related to externally manufactured products
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Contribute to root cause analysis and definition of corrective and preventive actions
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Lean Management & Continuous Improvement
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Drive or support continuous improvement initiatives within EM Q DP and across QA/IT matrix teams
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Apply lean management principles to streamline quality processes and improve efficiency
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Manage and coordinate the impacts of process changes on quality systems and CMO activities
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Align with stakeholders on planning, priorities, and deliverables
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Profile Requirements
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Education
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University degree with a scientific orientation (Bioengineering, Biology, Biotechnology, Pharmacology, Chemistry) or equivalent experience
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Experience & Knowledge
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5 years of experience in a GMP/cGMP environment (pharma, biotech, or similar regulated industry)
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Strong knowledge of GMP and regulatory requirements
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Experience in quality assurance activities: deviations, CAPA, change control, complaints management
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Experience in lean management, continuous improvement, and governance of processes
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Not a hands-on technical lab/production role – focus on process, governance, and QA oversight
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Knowledge of SAP and VEEVA is a strong asset
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Skills & Competencies
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Analytical and critical mindset, with a global and pragmatic approach
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Strong problem-solving skills
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Good impact and influence capabilities and networking skills to work efficiently within QA, IT, and other operational departments in a matrix organization
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Good technical writing skills (procedures, reports, rationales, quality documentation)
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Languages
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English: mandatory (oral and written)
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French is a plus
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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!