Yacht Life Sciences has a vacancy for a (Sr) GMP Specialist Quality Systems & Compliance to work for Janssen Biologics in Leiden and take part in their COVID-19 vaccine project.
The department Quality Systems & Compliance is responsible for (the improvement of) the compliance status within Janssen Biologics B.V. The main focus areas are: Inspection readiness, Internal auditing, GMP (Good Manufacturing Practices) training, Management review, CAPA management, Quality metrics, and Compliance gap assessments. They work closely together with the GMP departments within Janssen Biologics B.V. and associated companies worldwide.
Activities and responsibilities:
- You are responsible for one or more focus areas within the department.
- You make sure the GMP Quality Processes adhere to the applicable GMP regulations (e.g. Eudralex, FDA, ICH).
- You make sure the GMP Quality Processes are consistent within the organization through internal audits, gap assessments, and risk assessments.
- You are a key contact for GMP Compliance and/or training topics within Janssen Biologics and internationally (associated companies, Headquarters, Regulatory Agencies).
- You provide GMP advice to improvement projects and you have an active role in the implementation of such projects.
- You organize and support Health Authority inspections, 3rd party inspections, and Headquarters audits.
- You act as Lead Auditor during internal audits.
- You are Quality approver for improvements identified during inspections and audits.
- You make sure Performance, Quality, and Compliance reviews are generated.
- Bachelor/ Master degree or equivalent in biosciences, pharmacy or equivalent
- Minimum 8 years of pharmaceutical or related industry work experience, of which a substantial part in quality or compliance functions
- Working knowledge of GMP regulations and preferably knowledge of automated systems and/or validation
- Experience with Lean tools
- Excellent communication and advisory skills both in English and Dutch
- Proven leadership skills in a professional environment
- Able to translate complex situations to simple, practical solutions
- Able to influence people without formal authority
- Keen to recognize opportunities for improvement in and outside the department
- Proactive, result oriented, and team player
We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. This concerns a full-time secondment contract for 1 year (extension is possible). This position is open for freelancers/ ZZP as well.
We will offer a competitive benefits package in line with the seniority of the position (salary between 5500 and 6500 euro gross per 4 week period). You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
Janssen Biologics B.V. is a multinational pharmaceutical company that has been for more than 25 years a leader in the field of biomedicines. Through the dynamic science of biotechnology, we continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders (I.M.I.D.s), such as rheumatoid arthritis and psoriasis. Janssen Biologics is part of the Johnson & Johnson family of companies.
At Quality Assurance, they take a stand to consistently ensure the delivery of safe, cost effective and high-quality products for the patients in need. The QA department has a commercial and an NPD (New Product Development) & Launch branch. This position will be placed within the NPD & Launch group. QA NPD & Launch provides end-to-end Quality support (i.e. non-conformance management, CAPA, change control, validation and batch disposition) for their new biological products and vaccines. These products will be used in Clinical Studies to prove their safety and efficacy prior to their commercialization. This is a quick evolving and dynamic environment.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.