Quality Specialist Development (Leiden, NL)

Qabird; Leiden; On-site; EUR 72,000 - 100,000; Full time

Benefits offered by this job

Annual bonus

33 vacation days per year

Pension plan

Growth opportunities

Collaborative environment

Job summary

Pharming is seeking an experienced Quality Specialist Development to join the Quality Assurance team within Pharming Technologies B.V. You will serve as the QA Business Partner for CMC Development Teams, guiding quality decisions across development, validation, tech transfer, and commercialization.

Lead in GMP compliance, audits, and supplier management, ensuring alignment with EU and US requirements. A strategic, collaborative role with impact on therapies for rare diseases.

Qualifications

• Bachelor's or Master's degree in a relevant field (Pharmacy, Biotechnology, or Biopharmaceutical Sciences).
• At least six years in pharma/biopharma with QA experience.
• Strong knowledge of EU and US GMP regulations and development/manufacturing processes.
• Experience with audits, supplier management, and QMS tools (SAP, MasterControl).

Responsibilities

• Provide strategic QA guidance to the CMC Development Team throughout development, technology transfer and commercialization activities.
• Support and review development, technology transfer, validation, and commercial manufacturing activities.
• Contribute to the maintenance and continuous improvement of the Quality Management System, including quality documentation and quality agreements.
• Perform supplier qualifications and audits, and assess quality and compliance risks across internal and external stakeholders.
• Advise project teams on GMP, quality, and compliance topics, acting as a trusted coach and subject matter expert.
• Drive and support quality improvement initiatives while working closely with PQA Operations.

Skills

QA & GMP

Regulatory knowledge

Audits

Supplier management

Quality systems

Education

Pharmacy/Biotech degree

Tools

SAP

MasterControl

Job description

Contribute to the development of innovative therapies for patients with rare diseases

Are you an experienced Quality Assurance professional with a strong GMP background and experience in the pharmaceutical or biopharmaceutical industry? Would you like to play a key role in the development of innovative therapies that make a real difference in patients' lives worldwide? If so, we would love to hear from you.

About Pharming

Pharming is a global biotechnology company dedicated to developing innovative therapies for people living with rare diseases. Our mission is to improve patients' lives by addressing significant unmet medical needs. Quality, collaboration, and innovation are at the heart of everything we do.

Your work environment

As a Quality Specialist Development, you will be part of the Quality Assurance team within Pharming Technologies B.V. and serve as the dedicated QA Business Partner for one of our CMC Development Teams (Chemistry, Manufacturing & Controls). In this highly collaborative role, you will provide strategic quality oversight and expert guidance throughout the product lifecycle, from development and validation through technology transfer and commercialization. You will play a key role in influencing project decisions, and ensuring alignment with Pharming's quality standards and applicable EU and US GMP requirements.

You will work closely with colleagues across QA, CMC, Manufacturing, QC, Regulatory Affairs, Supply Chain, and R&D, while also collaborating with external partners, including contract manufacturers, laboratories, and suppliers.

What will you do?

• Provide strategic QA guidance to the CMC Development Team throughout development, technology transfer and commercialization activities;
• Support and review development, technology transfer, validation, and commercial manufacturing activities;
• Contribute to the maintenance and continuous improvement of the Quality Management System, including quality documentation and quality agreements;
• Perform supplier qualifications and audits, and assess quality and compliance risks across internal and external stakeholders;
• Advise project teams on GMP, quality, and compliance topics, acting as a trusted coach and subject matter expert;
• Drive and support quality improvement initiatives while working closely with PQA Operations.

What do you bring?

• Bachelor's or Master's degree in Pharmacy, Biotechnology, (Bio)Chemistry, Biopharmaceutical Sciences, Engineering, or a related field;
• At least six years of experience in a pharmaceutical or biopharmaceutical environment, including several years in Quality Assurance;
• Strong knowledge of EU and US GMP regulations and experience in pharmaceutical development, validation, and/or commercial manufacturing;
• Experience with audits, supplier management, and quality systems such as SAP, MasterControl, or similar platforms;
• Excellent communication skills, a proactive mindset, and the ability to influence stakeholders at different levels of the organization.

What can you expect from us?

• A challenging role within an innovative international biotechnology company.
• The opportunity to contribute directly to the development of therapies for patients with rare diseases.
• A competitive salary ranging from €72,000 to €100,000 gross per year, including 8.33% holiday allowance (based on a full-time position);
• Annual bonus scheme;
• 33 vacation days per year (based on a full-time position);
• An excellent pension plan;
• Opportunities for personal and professional growth;
• A collaborative, purpose-driven environment where your work helps bring innovative therapies to patients around the world.

Interested?

Please note: Due to the holiday period, applications will be reviewed from mid-August onwards. We appreciate your interest and will contact you as soon as possible regarding the next steps in the recruitment process.