Quality System Specialist

Location: Leiden  

Duration: 1-year contract

Hours: 40h

3 days per week onsite 

Imagine your next role as a  Data Integrity Specialist who will have the main focus on the quality system of Data Integrity. 

Responsibilities

This position has a main focus on Data Integrity with the following key responsibilities:

⦁ Supports the quality system of DI, including site governance, metrics, and coordination of all DI activities

⦁ Supports a site DI compliance dashboard, an overview of risks, initiates improvement activities to lower the risks

⦁ Acts as Data Integrity SME in the compliance part of Computerized System Validation.

⦁ Ensures consistency in the DI across processes and departments.

⦁ Has an outstanding knowledge of GMP regulations, Janssen, and J&J standards and translates these requirements into JBV systems that are compliant.

⦁ Maintains a relevant network of contacts with compliance specialists within JBV, JSC, and J&J companies.

⦁ Ensures good communication with all departments and functional groups within JBV involved in GMP work. Ensures that JBV management stays adequately informed.

⦁ Ensures that performance, quality, and compliance reviews are made, followed up, and shared with upper management.

Magnitude & Complexity

The focus of the function is to ensure that the core quality systems at JBV meet the current industry and regulatory standards, with a focus on Data Integity.   

The complexity lies also in the fact that the jobholder operates in a complex, multi-functional, and multi-site environment, where continuous improvement of the core quality systems is required. The position requires strong analytical and independent thinking and decision-making to find structural and regulatory-wise sound solutions for issues identified. Especially in outside contacts decisions and actions are occasionally reviewed.

Extensive, in-depth up-to-date knowledge of quality systems and recent developments in this expertise area is a requirement, with a clear focus on Data Integrity.

Numerous contacts will be maintained within JBV, and at JSC, Home Office, and J&J Corporate level but also with Regulatory Agencies and 3rd Parties. The job holder is expected to resolve matters effectively even when interests are conflicting. The job holder is able to negotiate a favorable solution for all parties involved. Outside contacts require tact and diplomacy.

how to succeed

The ideal candidate will have:

⦁ Master’s degree or equivalent in bioscience

⦁ Process Excellence/Lean belt, Risk Management, and Auditing experience are a plus

⦁ Pharmaceutical or related industry work experience for 8-10 years, of which a substantial part in functions related to Data Integrity

⦁ Experience in a complex, multinational work environment/company

⦁ Analytical, innovative, and pragmatic thinking

⦁ Proven leadership skills in a professional environment, including coaching or supervising multidisciplinary teams

⦁ Excellent communicational and advisory skills, result oriented. 

⦁ Excellent reporting skills, both in Dutch and English

benefits

This role offers a very competitive hourly rate & a supportive working environment. This contract will run initially for 12 months.

you are welcome here

Janssen is an innovative pharmaceutical company: we work every day on the frontline of health innovation. We can only meet this challenge because of our talented employees. Working at Janssen means that you get every opportunity to optimally develop your career.

about Janssen Biologics

Janssen is the Pharmaceutical Company of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen. 

https://www.janssen.com/netherlands/nl

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

questions

If you would like some additional information about the role please contact:  katerina.alikaridou@randstadsourceright.nl

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.