Description
Janssen Biologics, Johnson & Johnson Innovative Medicine, is currently recruiting a ( Senior) Manager AVA/Mycoplasma Quality Control within our Quality department. The successful candidate needs to have adventitious agent and mycoplasma QC testing experience, people and team management skills and a profound knowledge of pharmaceutical regulations/cGMP principles. You will be reporting to the QC Director Biotherapeutics.
About the Company:
Janssen Biologics B.V . is one of the Janssen Pharmaceutical Companies of Johnson & Johnson that has been for more than 25 years a leader in the field of biomedicines. 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. Janssen Biologics in Leiden is manufacturing key Biotherapeutic products, like Remicade, Stelara, and Simponi, and is also launching new products.
The QC laboratories department in Leiden is part of the supply chain (JSC) organization and is responsible for testing of raw materials, release and stability of Active Pharmaceutical Ingredients and Drug products manufactured at Leiden, other internal J&J sites and at external third parties. Leiden JSC QC is uniquely positioned as the worldwide HUB for Stability and for AVA and Mycoplasma testing. The AVA/Mycoplasma department consists of approximately 25 people.
You'll be part of the QC Management team working on successes for today and the future. You will lead with credo principles at hand ensuring diversity and inclusion, shaping, simplifying, and innovating the testing methods in close collaboration with Analytical Development (AD) colleagues. Your team will be onboarding several New Product Introduction (NPI’s) and pioneering automated testing solutions.
The responsibilities & the impact YOU will have:
- On time delivery of release and stability sample testing results
- Lead Supervisors and Technical specialists and provide operational guidance. Contributes to global strategies related to QC laboratories which align with compliance and business objects as well as the overall J&J vision.
- Act as a Servant Leader to coach and develop team members, driving business performance by successful talent development.
- Manage departmental budget, project budgets and resources; prepares staffing plans. Align roles and responsibilities of department to meet business needs.
- Collaborate with Quality Assurance, Stability Owners, Development, Manufacturing, Technical Operations, Engineering and Maintenance and other local and global stakeholders to support business needs.
- Responsible for timely completion of laboratory investigation of OOS/ invalid assays, CAPAs and change controls
- Ensuring tasks are performed in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Acting as change agent and build and maintain team capabilities to meet current and future needs.
- Setting goals and objectives for the department and define Key Performance Indicators that are indicative for excellent performance.
- Achieving innovation and excellence in business processes.
- Ensuring that data is generated, trended, and maintained according to current regulatory requirements, including data integrity.
- Sponsoring projects at site/department/quality level.
- Lead internal and Health Authority audits inspections and related investigations.
Qualifications
We would love to hear from YOU, if you have the following essential requirements:
- Masters / PhD or equivalent degree required in virology, microbiology, life sciences, biotechnology or equivalent.
- 5 - 10 years of experience in:
- Expertise in viral and microbiological method development and validation,
- Leading a med (> 20) sized specialized group (5-10 direct reports),
- Quality Control in pharmaceutical industry.
- Profound knowledge of pharmaceutical regulations/cGMP principles (FDA, EU, etc.) in general, and viral and microbiological topics specifically
- Organizational planning and problem-solving experience.
- Strong leadership & development qualities.
- Experience with principles of Process Excellence
- Good presentation skill
- Personal and social skills: informed decision making, digitalization and digitization, analytical thinking, Strong Quality Awareness and flexible.
- Prior experience with rapid microbiology testing methods is preferred.
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.
We are passionate about our work; we play vital roles across a range of professional fields 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.
- A dynamic and inspiring working environment,
- Opportunities to work on ambitious projects and assignments,
- Possibilities for further personal and professional development/education.
Janssen Biologics, J&J Innovative Medicine in Leiden, the Netherlands, is a leading site for commercial & clinical manufacturing in the dynamic business of Biotherapeutics and Vaccines. We combine our proven strengths with innovation to meet the needs of today and tomorrow. At J&J Innovative Medicine, enthusiastic people are working together in a dynamic culture where innovation and driven mentality are common good. We are proud of our Credo values and our diverse environment and commit to the highest safety, quality, and sustainability standards. The site and portfolio are growing rapidly which transforms the way we support our patients. Together, we strive for a future in which disease is a thing of the past. Passionate about our mission? Join our team. Make your mark.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through pioneering programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.