Quality Manager

Job Description - Quality Manager (2406184401W)

Quality Manager - 2406184401W

Description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

Within Johnson & Johnson Innovative Medicine, we are recruiting a Quality Manager as member of our QA - Clinical Supply Chain team based in Belgium (Beerse).

In the Research & Development area we develop treatments that improve the health and lifestyles of people worldwide. R&D development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, pulmonary hypertension and reproductive medicine.

Our department QA - CSC is responsible for the release and certification of Investigational Medicinal Products used in worldwide clinical trials guaranteeing product quality and compliance with applicable regulations.

As QA - CSC Quality Manager, you are responsible for ensuring that all operations within the QA-CSC organization adhere to the highest quality standards involving global internal and external partners. You ensure that products, services, and processes meet or exceed customer expectations and regulatory requirements. Being qualified as Qualified Person is an asset as this gives us the opportunity to combine the role of Quality Manager with back-up Qualified Person responsibilities for the legal entity Janssen Pharmaceutica NV.

Key Responsibilities:

- Develop and implement quality management strategies and systems to enhance overall quality performance

- Collaborate with cross-functional teams to identify areas for quality improvement and develop action plans while partnering with key stakeholders

- Act as delegate QP to certify Investigational Medicinal Products

- Supporting in change control, non-conformance handling and document management

- Drive automation and system driven solutions to optimize QA-CSC processes (e.g. applying PQM360 during release, driving Quality Improvement Plan improvements)

- Develop metrics, monitor and analyze quality data to identify trends and recommend corrective actions

- Communicate quality goals, metrics, and performance to management

- Lead or participate in continuous improvement initiatives to enhance operational efficiency and effectiveness

- Stay updated on industry standards, regulations, and best practices in quality management

- Provide training and support to employees on quality-related processes and procedures

- Conduct quality audits to assess compliance with quality standards

Qualifications

- University degree, scientific orientation (pharmaceutical, chemical or biological sciences/engineering) - Industrial Pharmacist (EU certified Qualified Person) is an asset

- 5 years’ experience in pharmaceutical industry

- Talented at quickly and easily acquiring new insights, with a strong desire to learn and stay up-to-date on emerging technologies and techniques

- A good understanding of pharmaceutical legislation, in cGMP regulations (domestic & international), ICH guidelines, policies, standards and procedures

- Strong knowledge of quality management principles and risk management

- Strong influencing, managerial and leadership skills

- Excellent analytical and collaborative problem-solving skills

- Excellent knowledge of English language (Dutch knowledge is a nice-to-have)

- Effective communication and have ability to build a network

- Ability to work independently and as part of a team

Proficiency in quality management systems and tools (COMET/Trackwise, Voyager Metrics Portal, ELN)

Join our team of professionals dedicated to achieving excellence in quality and ensuring customer satisfaction.

Johnson & Johnson is an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin,or protected veteran status and will not be discriminated against on the basis of disability.andEqual Employment Opportunity Posters GINA Supplement.

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