Description
Janssen Biologics is working on the establishment of a new Lentiviral Vector (LVV) production facility in Sassenheim, the Netherlands, as part of the Advanced Therapy (AT) Supply Chain of J&J.
This LVV Business Unit will become a key supplier for commercial LVV in support of the global Janssen BCMA CAR-T program for multiple myeloma, a disease affecting ~160,000 patients annually!
The LVV BU is currently in the Tech Transfer, finalizing qualifications, and getting ready for PPQ batches and regulatory site approval, and then starting routine production.
For the support of this facility, we want to strengthen the QA AT Quality Department with an Experienced QA Specialist specifically to provide QA oversight over the completion of the Tech Transfer process, and start-up of the manufacturing process.
To be successful as a Exp. Specialist Quality, we need candidates who demonstrate strong communication skills, a risk-based mindset, ability to zoom out and in, and great attention to details. Ultimately, an outstanding leader who engages, is well organized and drives Quality decisions. It is an exciting opportunity to have an impact to the health of patients worldwide!
If that applies to you and you are interested, please keep reading!
Key Responsibilities:
- You are one of the primary Quality contacts in the LVV BU, specifically for Quality Processes related to the start-up of production. You ensure compliance with all regulatory requirements particularly in relation to the pharmaceutical industry, health and safety requirements and environmental legislation and cGMP requirements.
- You set GMP standards and/or provide guidelines for the introduction of manufacturing processes, including the process controls, and the introduction of the materials and Single Use Systems.
- You ensure that the manufacturing process and all its controls are set up in line with the regulations and the license.
- You review and approve non-conformance investigations. You ensure appropriate corrective actions are implemented in a timely manner.
- You raise serious quality, compliance and or GMP incidents to Departmental or Project Management.
- You review and approve Change Controls and documentation, e.g., Work instructions and eBatch Records.
- You assess, review and approve study protocols and reports to assure that studies will be executed in a controlled and systematic manner conform cGMP and regulatory requirements e.g. but not limited to stability, validation.
- You use Risk Management tools in your daily work and actively advocate the use of those tools in the rest of the project team. You support and approve Quality Risk Assessments
- Explore opportunities to introduce emerging technological/digital solutions in Quality and drive these to implementation.
- Assist in the preparations for and during inspections (FDA, EMA etc.) to accomplish a successful audit.
- You actively take the lead in aligning requirements or expectations with our external (Quality) contacts within the LVV/CAR-T Supply Chain.
- You enjoy working closely and effectively with colleagues at the Site and globally, on sharing Best Practices and exceeding customer needs.
Location: Sassenheim, the Netherlands
Contract: Full Time / Part Time
Paygrade 25 @ Janssen Biologics BV
There are multiple vacancies available
Qualifications
Education:
- BSc in bioscience, chemistry, pharmacy or related subject with 4-6 years of experience.
- Msc in bioscience, chemistry, pharmacy or related subject with 2-4 years of experience.
Experience and Skills:
Required:
- Excellent understanding and application of Global Regulatory (cGMp/ICH/FDA/EMA) guidelines.
- Independent problem solver in a complex environment, balancing business need, regulatory requirements, and cost efficiency for all Quality decisions.
- Ability to drive teamwork in a fast-paced environment.
- Connect easily at all levels in the organization and leads by example.
- Embraces diversity and manages conflicting viewpoints.
- Empowered professional who drives a Quality Mindset and can make well motivated pragmatic decisions on their own.
- Proficiency in English both in word and in writing.
Preferred:
- Experience in Quality Risk Assessments have a strong preference.
- Working knowledge of Eudralex Annex 1 has a strong preference.
Other:
- Traveling is limited for the job. Working on-site will be required (flexible arrangement).
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.