GMP compliance specialist ATP

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Job Description:

J&J Innovative Medicine is recruiting for Data & Systems engineer, located in Leiden.

The Research & Development group of J&J Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases, cardiovascular and pulmonary hypertension.

The Advanced Therapies Pilot Plant (ATP) in Leiden produces clinical trial material for advanced therapies, a novel class of medical products that uses cell and gene therapies to treat diseases and have the potential to cure diseases when no treatment is available. It's a very exciting field, as no established manufacturing platforms exist for these products, which means that new processes need to be developed to ensure efficient production of high-quality GMP material

The ATP is a very active pilot plant, with 3 full GMP productions streets, making 5 different product types, and a 4th street with a Drug product fill line being created - making it a true end-to-end pilot plant The ATP teams also work in close collaboration with the process development teams to enable fast delivery of the products for clinical trials.

We are recruiting a GMP compliance specialist to join our teams. We are seeking a highly motivated and independent individual who will be very involved in all aspects of GMP compliance & EHS in the plant, from introducing new standards, to maintaining current standards and identifying and implementing improvements.

Key Responsibilities:

• Ensuring high quality and compliance standards by execution of nonconformances, CAPAs, corrections, through initiating and leading change controls and in coordinating, reviewing, coaching and training of employees in performing investigations. 
• Authoring, coordinating and reviewing documentation, both for the implementation of new standards and processes and for updating existing documentation.
• Actively participate in the department in both EHS and compliance associated tasks (e.g. pre audit interactive trainings, GEMBA, self-inspection follow up) to ensure compliance level is maintained and supports in audits.  
• Recommending and developing improvements to processes and procedures, related to EHS and quality standards.  
• Ensuring high safety standards through EHS chapter ownership

Qualifications

Education:

BSc or equivalent with 2-5 years or MSc or equivalent with 0-2 years of Pharma/biotech industry experience.

Experience and Skills:

• Good English verbal and written communication skills (Dutch preferred), including ability to effectively communicate with internal and external collaborators. 
• Excellent computer proficiency e.g. MS Office.  
• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution. 
• Able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude. 
• Strong connect and teamwork skills.
• Project management skills

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.

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