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About the vacancy
Quality
Quality Assurance
Quality Assurance
About Your Next Job
- 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
About Your Next Colleagues
- You will be part of the QA operational commercial product management team
- Work in close collaboration with other departments (Operations, warehouse, QC labs, MAM and Technical Operations)
- Become part of a worldwide network of QA experts within and beyond J&J
About Your Tasks and Responsibilities
- Act as Qualified Person for Large Molecule products
- Lead all aspects of complex site investigations and ensure that all CAPAs are implemented and effective within agreed timelines
- Manage the resolution of unexpected complex quality or compliance issues across the whole site (where needed)
- Manage and improve the GMP processes to facilitate the production and testing of Commercial products at JJIM
- Influence and manage 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
- Replace other QA-OCP MT members, and the Sr Manager OCP when needed
- Support inspection readiness programs and manage the process during Quality Regulatory inspections
About Your Skills and Experience
- 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
About Your Benefits
- Flexible working hours
- Your chance to be part of a global market leader
- A dynamic and inspiring working environment
- 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
- 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
- Service anniversary and recognition awards
- Subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans
Where Molecules Meet Opportunities
- Johnson & Johnson 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
- 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
- At Johnson & Johnson our culture enables dynamic and impactful careers
Only apply if...
- 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
Contact person
Frank Helmus
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