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Sassenheim.
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QA Specialist Sassenheim • Panda International
Gevraagd
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37 - 40 uur
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Medior/Senior
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Engels (taal)
Aanbod
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Tijdelijk contract
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Deels thuiswerken
Vacature in het kort
Sassenheim
Join a leading biopharmaceutical company as a QA Specialist - Advanced Therapies. Be the key QA representative, ensuring compliance with GMP and regulatory standards in a dynamic environment. Collaborate with cross-functional teams to maintain quality culture and inspection readiness. Enjoy a hybrid work model and the chance to contribute to impactful projects in cell and gene therapy. Embrace continuous improvement initiatives and participate in global QA projects. Continue reading to see how we can support your professional growth.
Over het bedrijf
Panda International
Volledige vacaturetekst
QA Specialist – Advanced Therapies
Sassenheim, Netherlands – Full-time, 1-year contract (possibility of extension)
Company Description
This leading biopharmaceutical company specializes in the development and manufacturing of advanced therapy medicinal products (ATMPs), with a strong focus on innovation, regulatory excellence, and patient impact. The Sassenheim site supports both clinical and commercial production of drug substances and starting materials for cell and gene therapy applications.
Job Description
As QA Specialist – Advanced Therapies, you will act as the primary QA representative for all quality-related activities across the production facility and QC laboratories. You will ensure compliance with GMP, cGDP, and regulatory expectations while serving as a key point of contact for internal stakeholders and external partners.
You will provide independent QA oversight for manufacturing operations, technology transfers, equipment qualifications, validations, and investigations, ensuring pragmatic, quality-driven decision-making in a dynamic environment. Working closely with cross-functional teams (Operations, QC, MSAT, MAM, Warehouse), you will help maintain and strengthen the site’s quality culture and inspection readiness.
Key Responsibilities:
Send your CV to Khanyi Mabena at via de button "Solliciteer nu" op deze pagina. or reach out directly at +31 20 20 44502 to learn more.
Sassenheim, Netherlands – Full-time, 1-year contract (possibility of extension)
Company Description
This leading biopharmaceutical company specializes in the development and manufacturing of advanced therapy medicinal products (ATMPs), with a strong focus on innovation, regulatory excellence, and patient impact. The Sassenheim site supports both clinical and commercial production of drug substances and starting materials for cell and gene therapy applications.
Job Description
As QA Specialist – Advanced Therapies, you will act as the primary QA representative for all quality-related activities across the production facility and QC laboratories. You will ensure compliance with GMP, cGDP, and regulatory expectations while serving as a key point of contact for internal stakeholders and external partners.
You will provide independent QA oversight for manufacturing operations, technology transfers, equipment qualifications, validations, and investigations, ensuring pragmatic, quality-driven decision-making in a dynamic environment. Working closely with cross-functional teams (Operations, QC, MSAT, MAM, Warehouse), you will help maintain and strengthen the site’s quality culture and inspection readiness.
Key Responsibilities:
- Provide QA oversight to manufacturing and quality control operations for advanced therapies at the site
- Supports setting the GMP standards and/or provides Quality guidance for:
- all GMP processes, e.g., Change Control, Doc Control, GMP Training, inspection readiness
- Facility, utility, and equipment design
- Technology and/or Analytical Transfer
- Qualifications and Validations
- Aseptic Processing and Annex 1 adherence
- Support GMP compliance across processes such as change control, document control, deviation/CAPA management, GMP training, and inspection readiness
- Review and assess quality investigations, root cause analyses, and product dispositions
- Guide and approve CAPAs and non-conformance management
- Lead or participate in risk assessments, internal audits, and global QA projects
- Oversee GMP training and contribute to a culture of continuous improvement and compliance through initiatives like GEMBA walks
- Represent QA in facility design and qualification projects (e.g., new Pollux facility)
- Serve as QA SME during audits and inspections (e.g., FDA, EMA)
- Review and approve documentation including protocols, reports, and change controls
- Participate in 24/7 QA on-call rotation for urgent quality issues
- MSc with minimum 4 years, or BSc with minimum 6 years of experience in a GMP-regulated environment (QA/QC/Manufacturing)
- Degree in Biochemistry, Biology, Pharmacy, or a related life science field
- Strong knowledge of GMP, Annex 1, ICH, FDA/EMA regulations
- Proven experience in pharmaceutical or biotechnological manufacturing environments
- Experience in process validation, technology transfer, and aseptic processing
- Ability to function independently, assess quality risks, and make well-justified decisions
- Proficient in English (Dutch is a strong plus)
- Familiarity with methodologies such as Process Excellence, Co-Think, or Kepner-Tregoe
- Experience in facility/utility qualification and large-scale site projects
- Prior experience in global QA roles or working with external CMOs/partners
- Experience with Aseptic Processing and Annex 1 adherence
- Location: Sassenheim, Netherlands (hybrid model)
- Contract Type: 1-year contract with potential for extension
- Start Date: ASAP
- Language Requirements: English required; Dutch preferred
Send your CV to Khanyi Mabena at via de button "Solliciteer nu" op deze pagina. or reach out directly at +31 20 20 44502 to learn more.
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