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!”