ABOUT BYONDIS
Byondis is an independent Dutch biopharma company in Nijmegen advancing antibody-drug conjugates (ADCs) and monoclonal antibodies (mAbs) for oncology and autoimmune disease. We run end-to-end CMC in-house from cell line development to aseptic drug product filling in GMP-certified facilities, complemented by select external partners. Our Quality Assurance organization safeguards patient safety and compliance across first-in-human and early clinical programs.
THE OPPORTUNITY
We’re hiring a Quality Specialist to serve as (or progress to) our Qualified Person (QP) for investigational products. If you’re already QP-certified, great. If not, and you bring the right technology match (ADC/mAb development and GMP manufacturing) and the ambition to qualify as a QP, we’ll back you with a clear pathway.
WHAT YOU WILL LEAD AND OWN
Quality Leadership & Strategy
- Set the QA strategy for a modality-rich pipeline (ADCs, mAbs) spanning USP/DSP, analytics, and aseptic fill/finish.
- Build a proactive, risk-based quality culture; drive right-first-time execution and continuous improvement.
GMP Oversight (In-house & External)
- Provide independent oversight of manufacturing, testing, release, and distribution of intermediates, drug substances, and IMP batches.
- Govern quality at CDMOs and testing labs; ensure phase-appropriate controls for early development.
Release & Certification
- The ultimate responsibility will be, the release of biotechnology-derived intermediates and drug substances manufactured in-house and provide QP confirmations for IMP certification.
Quality Management System (QMS)
- Own and evolve the QMS (deviations, CAPA, change control, complaints, management review, GxP procedures, internal/external audits, and manufacturing license compliance).
- Stay ahead of GMP/IMP requirements (EudraLex Vol. 4 and annexes); translate updates into pragmatic processes and training.
Inspection Readiness & Stakeholder Management
- Lead health-authority interactions and inspections.
- Partner closely with CMC, Manufacturing, Supply, and Clinical to balance speed, science, and safety.
WHAT YOU BRING
- Technology match: must have a minimum of 5 years deep QA/CMC experience with biologics , ideally ADCs and/or mAbs , including strong grasp of USP/DSP, analytics, and aseptic operations.
- Proven leadership in GMP environments (clinical stage preferred), with a risk-based mindset and hands-on approach.
- Track record shaping QMS, leading audits/inspections, and releasing clinical materials.
- Collaborative communicator who can influence across functions and with external partners.
- Language: fluent English and preferably Dutch
QP OPTIONS (Pick your path):
- Already a QP: Recognized under Article 49 of Directive 2001/83/EC and ready to act as QP for IMPs on day one.
- QP-in-Training: MSc in Pharmaceutical Sciences or related field (e.g., Biopharmaceutical Sciences, Medicine, (Bio)Chemistry, Biotechnology) eligible for QP recognition and motivated to complete remaining steps to qualification.
Nice to have: Prior QP experience for IMPs; ADC linker-payload familiarity; steriles/aseptic SME credentials.
What We Offer
- A mission-led environment where quality and science meet to deliver patient impact.
- Competitive salary (based on experience), pension, and 30 days’ annual leave (full-time).
- A supportive leadership team, state-of-the-art campus in Nijmegen, and company events that build community.
- Contract hours: 32–40 hrs/week.
- Location: Onsite in Nijmegen (relocation possible). This is not a remote role.
Join Byondis as QA Specialist and shape the quality agenda today, and grow into our QP tomorrow.