Manager QP Quality Assurance

Job Description:

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.

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)

Required Skills:

cGMP Practices, People Management, Pharmaceutical Quality Assurance

Hybrid work