QA Cryo Lead

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Business Process Quality

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Janssen Pharmaceutica is recruiting a QA Cryo Lead in Beerse, Belgium.

As a QA Cryo Lead:

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which works by harnessing the power of a patient’s own immune system. They are created from the patients’ own T-cells and are engineered to eliminate cancer cells expressing a specific antigen.

Johnson & Johnson is recruiting a QA Cryo Lead for its CAR-T Cryopreservation Center in Beerse, Belgium. Working closely with the QA Cryopreservation Manager, QA Cryo Supervisors and QA Cryo Associates, the role is accountable for the sustainability of EMEA CAR-T Quality Assurance at the Beerse Cryopreservation Centre

The responsibilities and the impact YOU will have:

Leadership Skills & Key Responsibilities:

- Partners with the QA Cryopreservation Manager to safeguard priorities and quality operational continuity, while independently driving assigned actions to completion.
- Provides management support to the QA Cryopreservation Manager and represents QA in relevant meetings and Tier discussions.
- Leads, coaches, and develops a team of QA Associates to achieve quality, business, and individual performance objectives.
- Leads end-to-end QA oversight of nonconformance and CAPA management within cCPC Beerse, driving risk-based decisions, ensuring the timely implementation and demonstrated effectiveness of corrective and preventive actions, and maintaining compliance with applicable GxP requirements and internal quality standards.
- Supports the optimization of QA MES processes and digital optimizations.
- Serves as the primary point of contact for QA Cryo.
- Collaborates with relevant cross-functional stakeholders (including Cryo Operations, Cryo Investigations, MES, IT, EQ, V2V, QA Ghent, and MSAT), for the quality oversight of projects and the effective resolution of operational issues.
- Aligns objectives and deliverables with other Quality functions and Quality Management to ensure a clear, consistent QA position. Communicates progress transparently and concisely and promptly communicates critical issues to Quality Management.
- Leads selected quality-focused meetings, ensures timely follow-up of actions, and monitors progress through relevant KPIs.
- Coordinates key GxP processes, including batch release, deviation management, change control, and other GxP documentation.
- Acts as a trusted subject-matter expert, providing clear oversight and sound quality guidance.
- Maintains audit and inspection readiness and supports preparation, execution and follow-up.
- Drives implementation of new regulatory requirements, including the SOHO Regulation, with a strong compliance mindset.
- Identifies improvement opportunities and implements lean solutions with a continuous improvement mindset.
- Coordinates and reviews relevant Quality Agreements and Site Master Files.

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

- Master’s degree in engineering, Science or an equivalent technical discipline, with experience in Quality Assurance/GxP manufacturing environment
- Minimum 5 years of relevant work experience.
- Prior experience in cell and gene therapy is preferred
- Proficiency in written and spoken English and Dutch, with strong communication skills and confidence in cross-functional meetings.
- A prior supervisory experience is a preference
- Understands the interplay between QA operational reality, compliance and patient impact, and makes clear, informed decisions.
- Preferably has knowledge of Tissues and Cells Directive, GTP,  legislation on human body material or SOHO.
- Leads by example and demonstrates well-developed people leadership skills that foster a strong sense of inclusion.
- Organized, Analytical, structured and solution-oriented, with a strong focus on people.
- Works independently while fostering collaboration around shared goals.
- Experience with batch record review, deviations, audits, validation, MES or Opstrakker is a strong asset.
- Feels comfortable working with a fully digital process flow. Experience working with SAP, COMET or eLIMS is a plus.
- Motivated to take ownership in a growing and evolving environment.
- Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity.

Standardized day shift, but must be open to support remote stand-by as required by clinical / commercial demand

Are you ready to make an impact?

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

#SCQuality

Required Skills:

Preferred Skills:
Business Process Management (BPM), Business Requirements Analysis, Business Savvy, Coaching, Communication, Compliance Management, Cross-Functional Collaboration, Data Savvy, Fact-Based Decision Making, ISO 9001, Leverages Information, Operational Excellence, Problem Solving, Process Optimization, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Standard Operating Procedure (SOP)

The anticipated base pay range for this position is:
€72,500.00 - €115,230.00

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.