Qualified Person
📍Brabant, Walloon Region, Belgium
About Nalys
Nalys is a fast-growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains. At Nalys, we believe in combining deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed. Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.
Job Description
As a Delegate Qualified Person within the QA team, you will play a key role in ensuring compliance with EU and Belgian regulatory requirements, GMP/GDP standards, and internal quality procedures. You will support both departments QA functions, contributing to the release of clinical trial materials, oversight of quality systems, and regulatory documentation. This role involves collaboration with global quality units, regulatory affairs, and external partners, and may include final release responsibilities for Asian depending on experience.
The Role & Responsibilities
Reporting to the QA leadership team and collaborating with cross-functional stakeholders, your responsibilities will include:
* Delegate Qualified Person (QP) responsibilities
* Perform QP certification and batch release for Extemporaneous Preparations and FING materials
* Approve QP release certificates, retest date extensions, study/country additions, and QP declarations
* Oversee deviations, change controls, complaints, and redistribution approvals
* Ensure clinical trial materials meet regulatory and GMP requirements
* Participate in quality metrics reviews and inform management of critical quality events
* Lead and support projects impacting both departments.
* Interact with internal quality organizations and regulatory bodies
* Participate in regulatory inspections and external audits
* Manage retention and reference samples at EU packaging partners
* Coordinate product retrievals and support Expanded Access Programs
* Ensure timely communication of critical quality issues to management and authorities
* Monitor and ensure effectiveness of CAPAs.
Skills & Qualifications
* You hold a Master’s degree in Pharmacy or equivalent scientific discipline
* You are recognized as a Qualified Person under EU regulations
* You have minimum 1 year of experience in a pharmaceutical environment
* You are fluently in English, in both spoken and written
* You work as an expert with GMP/GDP and regulatory compliance
* You manage perfectly documentation, communication, and are a problem-solver person.
Your Team
You will be part of the QA Delegate QP team, working closely with different quality units to ensure product safety, regulatory compliance, and continuous quality improvement.
The Recruitment Process
By applying for the “Delegate Qualified Person” position, you will go through the following steps in our recruitment process:
* Olivia Braszko, TA Specialist, will analyze your resume and cover letter and schedule a first screening
* You will have a second interview with one of our technical experts
* The final interview will be with our Business Unit Director, Jimmy Rousseaux.
“If you're passionate about pharmaceutical quality and want to contribute to safe and effective products that improve patients’ lives, we’d love to hear from you!”