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Quality

(Sr) Manager QC, Chemical, Physical and Raw Materials

  • 標題 (Sr) Manager QC, Chemical, Physical and Raw Materials
  • 功能 Quality
  • 子功能 Quality Control
  • 位置 Leiden, South Holland, Netherlands
  • 刊登日期
  • 參考 2206056543W
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描述

Janssen Biologics is currently recruiting a (Senior) Manager CPRm within our Quality Control 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:

Janssen Biologics B.V . is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is passionate about the development, production and marketing of antibodies and vaccines to prevent and combat diseases. At the Leiden site, dedicated and multi-skilled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points.

Within the QC laboratories of the Janssen in Leiden, the QC-CPRm laboratory is co-responsible for the release, stability testing of intermediate and final products (monoclonal antibodies and vaccines). Leiden QC is uniquely positioned as the J&J-worldwide center for Large Molecule (e.g., monoclonal antibodies) Stability testing. It represents various combined test labs classified based on specific techniques and/or expertise.

As a manager of this department, you will lead with the company values (named Credo) at hand, ensure of the diversity and inclusion of team building, simplifying and innovating the chemical and physical testing in close collaboration with Analytical Development and Material Science colleagues. The team that you will lead will be onboarding several new products and their associated methods. The team consists of three test-teams and a Raw Materials team, in total about 45 employees. The test teams are specialized teams: particle testing, liquid chemistry and spectroscopy. The raw material testing is outsourced, the Raw Materials team performances all the coordination of sampling, transporting and release.

You will be part of the QC Management team working on successes for today, tomorrow and the day after tomorrow fostering connected people, connecting things.

The responsibilities & the impact YOU will have:

  • Responsibility for the efficient and effective functioning of the team, ensuring (testing) activities are in line with the timelines, resources and budget.
  • Onboarding (transfer/co-validating) several New Products
  • Responsibility for the adequate qualified/ trained resources available for the (testing) activities needed in his/her team. Recruitment and hiring of personnel, ensuring proper onboarding and training.
  • Escalating (OOS/OOT) investigations and assay performance issues.
  • Operating with a flexible and sustainable team, able to absorb fluctuations to ramp up and down the testing to meet customer requirements and market demand.
  • Accountable for the performance and act as a Servant Leader to coach and develop team members to become successful in talent development and business performance.
  • 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.
  • Running the budget of the group and provide inputs for the OPEX and CAPEX budget
  • Achieving innovation and excellence in business processes
  • Ensuring that procedures and guidelines linked to safety, environmental and health are met.
  • Ensuring that overall compliance to regulatory cGMP requirements, global standards, procedures, etc.
  • Ensuring that data is generated and maintained according to current regulatory requirements, including data integrity
  • Coordinating the inhouse services providers and their contract providing general assistance to the labs
  • Sponsoring strategic and capital projects at departmental and site level.

資格

We would love to hear from YOU, if you have the following requirements:
 

  • Master degree in life sciences, chemistry, biotechnology or equivalent
  • 8-10 years of proven experience in a Quality or related environment, of which 4 or more years in a people leadership position.
  • Experience in Quality Control.
  • Profound knowledge of pharmaceutical regulations/cGMP principles
  • General knowledge of pharmaceutical development & manufacturing
  • Organizational planning and problem-solving experience
  • Strong leadership & development qualities
  • Experience with principles of Process Excellence, Lean manufacturing, etc. is a pre.
  • Good presentation skill
  • Strong command of English
  • Managing and leading a medium-large (40-50) size specialized group (8-10 direct reports)
  • Personal and interpersonal skills: self-starting, informed decision making, analytical thinking, strong quality awareness and flexibility

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 ~2000 people who work here, or you’re considering joining the team, we offer:

  • A full-time contract with 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

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