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**Job Function: **
Quality
**Job Sub Function: **
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Beerse, Antwerp, Belgium
Job Description:
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 requirements.
- Provide Quality oversight to apheresis/cryopreservation facilities.
- Monitor trends, identify issues, recommend, and implement appropriate actions.
- Performs duties under limited supervision and according to standard operating procedures.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP/GTP requirements.
- Coordinate and provide concurrences on deviations, change controls, and CAPAs.
- Review relevant regulatory documents prior to submission.
- Other duties will be assigned, as the need arises.
Qualifications
Education:
- Minimum of a bachelor’s degree in Science, Medical or equivalent technical field is required.
- Minimum of 8 years industry related experience is required.
- Experience providing quality oversight of a pharmaceutical manufacturing, laboratory, or clinical study site is required.
- Good written and verbal communication skills are required.
- Critical thinking skills and ability to focus on detail is required.
- Knowledge of cGMP regulations preferred.
- Knowledge in clinical quality, cell therapy, or Research & Development preferred.
- Understanding of Data Analytics to drive performance preferred.
- Soft Skills: Leading by influencing, convincing, negotiation Stakeholder management in a complex matrix organization
- Proficient in current business productivity software and GMP records systems (i.e., Comet) preferred.
- Approximately 30% travel will be required.
Location: EMEA region
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.
**Required Skills: **
Preferred Skills:
Business Alignment, Coaching, Collaborating, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility
The anticipated base pay range for this position is:
€79 800,00 - €137 770,00
Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.