Manager QP Quality Assurance

 Bij Johnson & Johnson geloven we dat gezondheid alles is. Onze kracht op het gebied van innovatie in de gezondheidszorg stelt ons in staat een wereld op te bouwen waar complexe ziekten worden voorkomen, behandeld en genezen, waar behandelingen slimmer en minder invasief zijn en oplossingen persoonlijk zijn. Dankzij onze expertise op het gebied van innovatieve geneeskunde en MedTech bevinden we ons in een unieke positie om vandaag de dag te innoveren in het volledige spectrum van zorgoplossingen om de doorbraken van morgen te realiseren en een grote impact te hebben op de gezondheid van de mensheid. Ga voor meer informatie naar jnj.com

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Functie:

Quality

Subfunctie functie:

Quality Assurance

Functiecategorie:

Professional

Alle vacaturelocaties:

Leiden, South Holland, Netherlands

Functieomschrijving:Functieomschrijving:

We are looking for an enthusiastic and motivated colleague who will help us to strengthen our QA team of Johnson & Johnson Innovative Medicine (JJIM) in Leiden, The Netherlands. Somebody who would like to contribute to a high-quality organization of the site and J&J.

The Manager/QP will be be the linking pin in the investigations into quality issues and with that will be responsible for the improvement of the overall quality status of the site. You will be part of the QA operational commercial product management team and will work in close collaboration with other departments (Operations, warehouse, QC labs, MAM and Technical Operations). The position provides a unique opportunity to work on the latest and future technologies in biopharmaceutical manufacturing, and you will become part of a worldwide network of QA experts within and beyond J&J. The activities are very dynamic and varied. The candidate likes challenges, doesn’t avoid problems and enjoys working in various teams.

 

About the Company: JJIM 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, such as rheumatoid arthritis and psoriasis. JJIM is part of the Johnson & Johnson family of companies. The department Quality Assurance sees to that quality systems are applied as per GMP standards and is responsible for handling non-conformances, bulk (PFB / FB) and intermediate (DPC / CSS) release and change control. In addition, the department is responsible for providing quality oversight and support during daily operations activities. With that, the QA department plays a significant role in providing advice on quality topics to all departments of the supply chain.

We are looking for an enthusiastic and driven colleague who can take up this challenging role as Manager QA. The responsibilities & the impact YOU will have:

• The manager/QP leads a team of 6-10 QA specialists
• Manages, leads & motivates the QA OCP department and its people to enhance performance and achieve business goals, agreed metrics & budgets
• Act as Qualified Person for Large Molecule products
• Ensure that in a timely manner a clear and quality prospected advice is given to all cGMP and/or quality related issues encountered during (non)routine operations. Lead all aspects of complex site investigations and ensure that all CAPAs are implemented and effective within agreed timelines.
• Manages the resolution of unexpected complex quality or compliance issues across the whole site (where needed)
• Manages and improves the GMP processes to facilitate the production and testing of Commercial products at JJIM
• Influences and manages regulatory and corporate expectations and relationships to ensure alignment of the site’s quality systems, projects and programs to maintain GMP compliance, with special focus on Commercial product manufacturing and compliance.
• Raise serious quality, compliance and /or GMP incidents to Site or Global Management.
• Replaces other QA-OCP MT members, and the Sr Manager OCP when needed
• Supports inspection readiness programs and manages the process during Quality Regulatory inspections

 

Kwalificaties - Extern

We would love to hear from YOU, if you have the following essential requirements

• University degree at a master level in relevant discipline, e.g. biosciences, pharmacy, analytical chemistry, process technology or engineering
• Minimum of 6 years’ experience in quality and/or similar GMP environment in pharmaceutical, consumer or medical device company, of which minimum 2 in a managerial, people leading role
• Eligible as QP
• Perfect written and oral communication skills in Dutch and English
• Team player, and ready to take a stand when necessary.
• Strong quality mentality
• Knowledge of current Quality Management principles, GMP and Quality Systems Pharma regulations (cGMP/ICHIFDA/EMA)

 

This is what awaits YOU at J&J: This is an opportunity to work with a highly motivated team and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement. We are passionate about our work; we play vital roles across a range of professional subject areas and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. Whether you’re one of the ~2000 people who work here, or you’re considering joining the team, we offer:

• Flexible working hours
• Your chance to be part of a global market leader.
• A dynamic and inspiring working environment.

 

 

Vereiste vaardigheden:

cGMP-praktijken, Farmaceutische kwaliteitsborging, People management

 

 

Gewenste vaardigheden:

  

 

Het te verwachten bruto jaarsalaris voor deze functie ligt tussen de:

€68 600,00 - €119 600,00

 

 

Voordelen:

Naast het basissalaris bieden wij de volgende benefits*: Een jaarlijkse bonus met een vast percentage (% van het salaris) afhankelijk van de salarisschaal / land, waarbij het werkelijke bedrag is gebaseerd op de prestaties van de werknemer en de onderneming in het voorgaande kalenderjaar, of verkoopcommissies. Bovendien bieden wij vakantiedagen, minimaal 12 weken ouderschapsverlof, verlof bij overlijden van directe familie, zorgverlof, vrijwilligersverlof en welzijns programma's voor financiële, fysieke en geestelijke gezondheid. We bieden ook jubileum- en erkenningsbeloningen aan en afhankelijk van de voorwaarden van hun respectieve plannen, kunnen medewerkers - en in sommige locaties hun aanverwanten - deelnemen aan verschillende verzekeringsplannen. Ga voor meer informatie naar Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*dit is alleen voor informatieve doeleinden. Bedragen en werkelijke benefits kunnen per land verschillen en kunnen worden gewijzigd.