Description
- We are looking for two headcounts in Leiden; the two roles will be leveled according to experience.
Change lives for the better.
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/.
THE OPPORTUNITY
Are you ready to take on a pivotal role in our Quality Control department for Advanced Therapies? This is an exciting opportunity to become an Investigation Lead in our team.
At JnJ Biologics B.V., a part of Johnson & Johnson Innovative Medicine, we are driven by our passion for the development, production, and promotion of advanced therapies and other biotherapeutics to combat and prevent diseases. Our Leiden site fosters a high-performance culture driven by innovation and a "can-do" mindset.
As the QC Advanced Therapies laboratory within the Janssen Supply Chain, we have the responsibility to support production activities in Leiden and conduct QC release and stability testing for Leiden and other production sites across the Janssen Supply Chain network. Our QC Advanced Therapies department is focused on enhancing the structure and content of quality investigations. The Investigation Lead will support the QC AT team by addressing lab-related non-conformances and change controls, working collaboratively with operational testing teams to drive continuous quality improvement in our laboratories.
The responsibilities & the impact YOU will have:
- The investigation lead collaborates effectively with supervisors, technicians, technical specialists, production, QA, and global stakeholders such as DPDS AD.
- Lead complex investigations and prepare clear, scientifically sound quality records. Initiate and compile final reports based on thorough troubleshooting, defining and implementing corrective actions while monitoring their effectiveness, ensuring timely execution and closure.
- Lead multidisciplinary teams when investigations extend beyond departmental boundaries.
- Communicates and presents investigational status and results to local and global stakeholders, as well as leadership teams.
- Escalation management of non-conformances/quality deviation according to global procedure, acting as QC escalation lead.
- Review and update relevant documentation, including Standard Operating Procedures (SOPs), Work Instructions, and other related materials.
- Initiate, assess, and follow up on global and local QC AT-related change controls.
- Support, initiate, and implement improvement projects focused on safety, quality, efficiency, and customer satisfaction.
- Conduct training and awareness sessions within the QC AT team.
- Assist during health authority inspections, including preparation for and response to inquiries related to investigations and remediations.
Qualifications
We would love to hear from YOU, if you have the following essential requirements:
- Master’s degree in biotechnology or a related field, with a minimum of 4 years of proven experience in Good Manufacturing Practice (GMP), preferably in a Quality Control setting.
- Strong quality awareness, regulatory knowledge of cGMP, and experience with authority inspections and expectations.
- A comprehensive understanding of laboratory processes, techniques, procedures, and systems.
- A well-developed, structured approach to problem-solving and critical thinking, coupled with strong organizational skills.
- Gathers and integrates information to support strategic decision-making, employing a range of data analysis tools, techniques, and methodologies.
- Display the ability to work independently as well as part of a team.
- Excellent interpersonal and communication skills, capable of effectively conveying information to diverse audiences.
- Proficiency in English, both oral and written, with the ability to effectively communicate technical deviations in writing.
- Display resiliency and adaptability in a fast-paced, ever-changing environment.
- Familiarity with systems such as COMET, Truvault, eLIMS, SAP, and Summit is a plus.
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 disciplines and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers.
Whether you’re one of the thousands of people who work here, or you’re considering joining the team, we offer:
- Flexible working hours.
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment, including operating globally.
- Opportunities to work on challenging projects and assignments.
- Possibilities for further personal and professional development/education.
- Excellent Benefits.
Closing date: Friday, 7th of March 2025.
Being part of Johnson & Johnson can change everything, including YOU
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.