Vacature Sr MGR Quality Assurance new Products

Carrières

Sr Mgr Quality Assurance New Products

• Titel Sr Mgr Quality Assurance New Products
• Functie Quality
• Sub functie Quality Assurance
• Categorie Senior Manager, Quality Assurance (PL8)
• Locatie Leiden, South Holland, Netherlands
• Gepost mei 24 2024
• Referentie 24W

Beschrijving

Johnson & Johnson is currently seeking a

Sr Manager Quality Assurance Biotherapeutics New Products (m/f/d)

to join our team located in Leiden, Netherlands.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

Job summary:

The Sr. Manager Quality Assurance New Products is responsible for making sure that the quality systems are applied as per GMP standards within Janssen Biologics for the introduction, manufacturing and testing of New Products and clinical supplies.

Janssen Biologics Leiden Operations delivers key commercial Biotherapeutic products (API) like Remicade, Simponi and Stelara, but has also build a strong expertise in Vaccines and Viral vector production and testing activities. Currently the site is also starting the introduction of Gene Therapy Products.

Activities within the Quality department comprise the full spectrum of Quality processes (e.g. Product Release, Changes, Non-Conformances, CAPAs, Method and Process Transfer, Process and Cleaning validation, QA oversight on Quality Control activities etc).

The Sr. Manager is a member of the Quality Management team, and as such plays a major role in providing advice on Quality topics to all departments, which are part of the Supply chain. 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 Janssen.

In addition, your personal leadership skills will be asked for, and will be further developed, in your continuous shaping and improving of the QA function.

Responsibilities & Accountabilities:

• Manages, leads & motivates the Quality Assurance department and its people to enhance performance and achieve business goals, agreed metrics & budgets
• Manages and improves (leading to acceleration of) the GMP processes to facilitate the production and testing of new & clinical Biotherapeutic and Advanced Therapy Products at Janssen Biologics.
• Manages the resolution of unexpected complex quality or compliance issues across the whole site (where needed)
• 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 Clinical products and commercial launch process.
• Supports or leads (global) escalations of issues, which have (potential) impact on the delivery of our Biotherapeutic and Advanced Therapy products
• Replaces other QA management team members, and the Site Quality Head when needed
• Participates in operational, quality and capacity projects, and acts as SME on Quality topics
• Supports inspection readiness programs and manages the process during Quality Regulatory inspections.

Kwalificaties

Key skills and competencies required:

• University degree at a master level or equivalent in relevant discipline, e.g. biosciences, pharmacy, analytical chemistry, process technology or engineering.
• Minimum 8-10 years experience in quality and/or similar GMP environment in pharmaceutical, consumer or medical device company of which minimum 5 years in a managerial, people leading role
• Knowledge of current Quality Management principles, GMP and Quality Systems Pharma regulations.
• Qualifications as QP (or eligible to) would be a plus. Team player, and ready to take a stand when necessary.
• Expertise in Pharmaceutical Sterile Drug Product manufacturing would be a plus.
• Good written and oral communication skills in Dutch and English
• Team player, and ready to take a stand when necessary

What we offer:

Our employees are just as important to us as our customers. At Johnson & Johnson, we like to think long-term and enable successful careers with interesting career paths within our company. We do everything we can to enable you to develop your full potential with us.

We are very proud of our open, appreciative corporate culture and value a healthy balance between work, family and leisure. Flexible working time models such as part-time, flexible time and home office can be adapted to your life. Our proactive health program and our company fitness center take care of your mental and physical well-being.

Functie:	quality assurance new product
Startdatum:	24-5-2024
Ervaring:	Ervaren
Educatielevel:	WO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

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