Qualified Person (QP)

About Byondis

Byondis is an independent Dutch biopharmaceutical company in Nijmegen, delivering breakthrough solutions in oncology. We design and develop wholly owned antibody–drug conjugates (ADCs) and monoclonal antibodies (mAbs), advancing a pipeline that targets validated cancer biology with novel mechanisms of action, optimized linker technologies, and a broad range of payloads. Our R&D and world-class GMP manufacturing are fully integrated in-house, enabling end-to-end control from discovery to clinical supply.

Our Chemistry, Manufacturing & Controls (CMC) teams span cell line development through aseptic drug product filling. We manufacture mAbs and ADCs in our GMP facilities and partner externally for specialized GMP testing and drug product manufacturing. QA safeguards compliance and patient safety across our first-in-human programs.

The Role

As a Qualified Person (QP) within QA, you are the final safeguard for quality and regulatory compliance across Byondis’ early clinical assets

Your impact

Manufacturing oversight

• Provide independent QP/QA oversight of production, testing, and distribution for intermediates, drug substances, and IMP batches.

Release & certification

• Hold ultimate responsibility for release of biotechnology-derived intermediates and drug substances manufactured at Byondis, ensuring full regulatory compliance.
• Issue QP confirmations supporting IMP certification.

Compliance & continual improvement

• Maintain and improve the Quality Management System (deviations, change control, complaints, management reviews, internal/external audits, GxP procedures, manufacturing license).
• Track and interpret evolving GMP and IMP guidance; communicate changes and drive timely alignment.
• Advise CMC teams on GMP requirements for IMPs and source materials ; act as SME for ADC/mAb modalities, aseptic processing, and IMP quality.
• Represent Byondis during health authority inspections , ensuring inspection readiness and robust compliance culture.
• Champion quality training and behaviors that reinforce right-first-time execution and continuous improvement.

What You Bring

You’re a quality-driven biopharma professional with strong technical grounding in development/manufacturing. You thrive in fast-paced, early-development settings, applying a risk-based, pragmatic approach across complex topics. You collaborate fluently across QA, CMC, and external partners  and you take ownership from plan to proof.

Qualifications

• MSc in Pharmaceutical Sciences or related (Biopharmaceutical Sciences, Medicine, (Bio)Chemistry, Biotechnology), recognized for QP (or proof that you are working towards becoming a QP).
• ≥5 years in the biopharma industry, ideally across QA, development and/or manufacturing, with solid USP/DSP understanding.
• Strong grasp of cGMP and IMP regulations
• Fluent in English and preferably Dutch
• Prior QP for IMPs experience advantage.
• Familiarity with aseptic processing for drug product manufacturing  advantage

Why Byondis

Work where platform science meets execution: integrated discovery, GMP manufacturing, and an ADC/mAb pipeline built for selectivity, diversity, and therapeutic .You’ll join a culture anchored in integrity, authenticity, entrepreneurship, quality, and trust on a state-of-the-art campus in Nijmegen, Netherlands

We offer

• Competitive salary (based on experience)
• Pension scheme & 30 days annual leave (full-time)
• Company events and a collaborative, mission-driven environment
• Contract hours: 32–40 hrs/week
• Location: Onsite in Nijmegen (relocation possible)
• Not a remote role

Please send your application before 04 October 2025.