DirecciónDescription
At Johnson & Johnson, we are working to build a world without disease. Redefining lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.
We bring together the best minds and pursue the most promising science. This position manages external partners that collect Apheresis Material and Cell Laboratories that perform Cryopreservation activities used in autologous CAR-T products for clinical trials and commercial treatment.
Job duties are performed within a team schedule and collaboration with key partners!
Key Responsibilities :
- Audit sites to ensure compliance with Janssen and Health Authority Demonstrates sufficient knowledge outside own expertise domain, especially in bridging disciplines
- Provide Quality oversight to apheresis / cryopreservation facilities.
- Significant contribution to and or lead of EQ projects / process owner of major process (QO, lead of competence group, ...)
- Monitor trends, identify issues, recommend, and implement appropriate actions.
- Participating in teams on platform level and able to do a developmental leading expert assignment on a platform or global level
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP / GTP requirements.
- Coordinate and provide concurrences on deviations, change controls, escalations and CAPAs.
- Review relevant regulatory documents prior to submission. Review internal standards and or regulations.
- Spokesperson for health Authority Inspections for several knowledge area’s, representing EQ in the Audit Preparation Meetings.
Lead for the audit CAPA plan.
Qualifications
Education :
- Minimum of a bachelor’s degree in Science, Medical or equivalent technical field is required.
- Minimum of 10 years industry related experience is required.
- Minimum 5 years of experience in the QA Role and CAR-T experience
- Good written and verbal communication skills and negation skills are required.
- Critical thinking skills and ability to focus on detail is required.
- Knowledge of cGMP / GTP regulations preferred.
- Knowledge in clinical quality, cell therapy, or Research & Development preferred.
- Proficient in current business productivity software and GMP records systems (i.e., Trackwise, COMET, ) preferred.
- Adapts to unforeseen circumstances and can manage re-scheduling of work because of unanticipated events.
- Approximately 35% travel will be required.
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.
