Senior Supervisor Release & Stability QC - 2406200466W

Description

Janssen Biologics is currently recruiting a Senior Supervisor Release & Stability within our Quality Control department due to the expansion of the Release & Stability (R&S) team to more than 20 people. The successful candidate needs to have QC testing, stakeholder management and people leadership experience in the biologics/pharmaceutical/manufacturing industry with a relevant educational background. The candidate is accountable for managing a part of the R&S team, which main responsibility is the end-to-end oversight for release and stability product testing within Leiden QC. Furthermore, the team takes ownership for other tasks, such as: complaint testing, external lab testing, lab material shipments to local operation companies, raw data request handling and reference material management.

The responsibilities & the impact YOU will have:

• Lead a team of direct reports of 8-12 (associate) analysts and associate scientists.

• Ensure that procedures and guidelines linked to safety and health are met.

• Mentor, coach, train and develop the personnel of the R&S team. Evaluate performance and provides opportunities for growth.

• Ensure overall compliance to regulatory cGMP requirements, global standards, procedures, etc.

• Proactively partners with stakeholders to position the Leiden QC department as large molecule stability hub, Ava/Myco testing hub and release testing for commercial products.

• Manage end-to-end product testing for release and stability within Leiden QC.

• Accountable for subset of other tasks within the team (see description in job summary).

• Leading role during GMP inspections and ensures the team members are subject matter experts on R&S subjects.

• Act as a backup for the QC R&S Manager.

Qualifications

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

• Master degree in chemistry & biotechnology or equivalent by experience with minimal 6 years’ experience in the pharmaceutical industry.

• Experience in managing people (direct report lines).

• Strong leadership & development qualities.

• Experience in Quality Control, stakeholder management, etc.

• Profound knowledge of pharmaceutical regulations/cGMP principles (FDA, EU, JPN, etc.).

• General knowledge of pharmaceutical development & manufacturing.

• Organizational planning and problem-solving experience.

• Strong Quality Awareness.

• Experience with principles of Process Excellence, Continues Improvement, etc.

• Good presentation skills.

• Excellent knowledge of English.

• Accurate and analytical mindset.

• Team player, and ready to take a stand when necessary.

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 subject areas 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

• Your chance to be part of a global market leader

• A dynamic and inspiring working environment

• Opportunities to work on exciting projects and assignments

Johnson & Johnson Family of Companies are equal opportunity employers, and 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.

Please note that due to the holiday period this role will be open for application until midnight on Sunday 11th August.

Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden

Organization Janssen Biologics (7266)

Job Function Quality Control

Req ID: 2406200466W