Qualified Person

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Leiden, South Holland, Netherlands

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 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:

• 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

Qualifications:

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

• Strong quality mentality
• Knowledge of current Quality Management principles, GMP and Quality Systems Pharma regulations (cGMP/ICHIFDA/EMA)

• Perfect written and oral communication skills in Dutch and English
• Team player, and ready to take a stand when necessary.

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.

A pre-identified candidate for consideration has been identified. However, all applications will be considered

Required Skills:

Preferred Skills:

AI solution evaluation, Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Tactical Thinking, Team Management

The anticipated base pay range for this position is:

€76 000,00 - €121 440,00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Additional information:

The Netherlands: 8%.The annual base pay includes an 8% holiday allowance.

Het bruto jaarsalaris is inclusief vakantietoeslag van 8%.