Janssen Pharmaceutica is recruiting for the Change Control Coordinator for the Manufacturing Excellence CAR-T EMEA organization, located in Ghent Belgium.
The Manufacturing Excellence CAR-T EMEA organization is an organization which provides and supports a high degree of assurance that specific processes will consistently produce and meets its pre-determined specifications by deploying process validation, process system engineering, data architecture and continuous process verification and process investigation.
The team will drive process optimizations to enable seamless transition from clinical to commercial operations.
- The Change Control coordinator is supporting the Change Control management E2E, including pre-CoC, assessments and follow up on timely execution, supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
- The function has the responsibilities for supporting the change control document management process within a cell therapy manufacturing facility to support both clinical and commercial documentation requirements in a sterile GMP environment. This role will ensure compliance within the document
management systems (Trackwise).
When a Change Control should be initiated within the CAR-T Belgium organization, the individual will be handed over the overall responsibility in line with the global and local Change Control procedures. This includes:
- Identify the necessary stakeholders to be involved in the change.
- Schedule and lead the kick-off/pre-CC meeting, if required.
- Create the parent and child records in Trackwise based upon the outcome of the stakeholder alignment.
- Keep the oversight on timely completion of the different assessments in the Change Control.
- Bring the Change Control to the CAPA/CC/Technical Board, if required.
- Follow-up on the timely approval of the Change Control to get it into Execution Plan.
- Monitor the (post-) implementation activities for timely completion and the related documentation in the Trackwise system (incl the necessary evidence of execution).
- Drive the Change Control until timely closure.
- Escalate in case of delays, issues, etc to senior leaders.
- Provide technical leadership for change record Life-Cycle Management and drives continuous improvement.
- Actively support and participate in all regulatory and internal audits of the processes.
- A minimum of a Bachelor’s Degree or higher in Science, Bioengineering, pharmacy or related discipline, or equal by experience.
- GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 1).
- Operational experience with electronic quality systems as Trackwise / TruVault is required.
- Strong written and verbal communication skills, and analytical problem solving and conflict resolution skills.
- Flexible, highly motivated, with strong organization skills, ability to multi task with attention to detail.
- Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
- Proficient knowledge of Microsoft Office.
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
- Have advanced computer skills to increase department's productivity, as well as boarding technical and scientific knowledge.
- Fluent in written and spoken dutch and english
- It is preferable that the candidate have experience working in an aseptic
manufacturing facility, preferably in quality assurance, manufacturing
compliance, clinical quality, or cell therapy.
- Team player
- Ability to interact at different levels of the organization
- Ability to work under pressure, handle conflicting interests, and take decisions
- Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly