Vacature Sr. Manager Micro

Sr. Manager Micro/AVA/Myco

• Titel Sr. Manager Micro/AVA/Myco
• Functie Quality
• Sub functie Quality Control
• Locatie Leiden, South Holland, Netherlands
• Gepost feb 11 2024
• Referentie 24W

Beschrijving

Janssen Biologics is currently recruiting a Senior Manager Micro/AVA/Myco within our Quality department. The successful candidate needs to have QC testing and manager leadership experience in the biologics/pharmaceutical/manufacturing industry with a relevant educational background.

About the Company:

At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working diligently to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

The Leiden QC laboratory is part of the Janssen Supply Chain and ensures release, stability testing of intermediate and final products (monoclonal antibodies and vaccines). Leiden QC microbiology team is uniquely positioned as the worldwide HUB for AVA and Mycoplasma testing. The Microbiology department consists of 2 sub-teams: a bacteriology lab and an AVA/Mycoplasma lab, with a team of around 60 people. The Senior Manager will report to the QC Director Biotherapeutics. You'll be part of the QC Management team working on successes for today, tomorrow and the day after tomorrow, fostering connected people and connecting things. 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 microbiological testing solutions.

The responsibilities & impact YOU will have:

• On time delivery of in process control, environmental monitoring, 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/LM quality level.
• Lead internal and Health Authority audits inspections and related investigations.

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:
  • Microbiology with expertise in viral and microbiological method development and validation,
  • Leading a mid(> 20) sized specialized group (5-10 direct reports),
  • Quality Control.
• 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 skills
• 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.

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.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

Functie:	manager micro
Startdatum:	16-02-2024
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met Johnson & Johnson via onbekend of onbekend. Of bezoek hun website onbekend.