J&J Family of Companies Computerized Quality Systems Specialist in Leiden, Netherlands
The Quality Assurance department has a vital position in the JSC organization. The department is responsible for the maintenance of the compliance standards, for the release of raw materials and products, for the review, approval and archiving of the GMP documentation and for training.
The automation of Quality Systems is of growing importance in the Quality processes. As most of these systems are globally used at Johnson & Johnson sites over the world the technical IT part is managed in the centrally. Testing, implementation of new functionalities, maintenance of masterdata and documentation and training is organized at site level. The need for Computerized Quality Systems in the field of Event, Change Control, Document and Training management is instrumental for pharmaceutical companies.
The Computerized Quality Systems Specialist is part of the Quality Systems & Compliance department within Quality Assurance. This department is responsible for Compliance, Training, Document Management and Data Integrity. The Quality Systems Specialist takes the lead in, and is part of, local and global Computerized Quality Systems initiatives and projects. The projects are in cooperation with the global organization and in alignment with the business needs. The jobholder will be an important member of global project teams as Janssen Biologics BV is one of the largest users of the systems.
Ensures a professional, up to date, high quality level of JBV’s core Computerized Quality Systems and ensures the deployment of these systems. Maintains and improves the GMP compliance and technological status of JBV’s systems in line with the regulatory, JBV, Janssen Supply Chain and J&J standards. Is part of the Global community that develops, updates, tests and implements the Computerized Quality Systems and procedures. Advises Site Management and actively supports the executing departments regarding improvements of the Computerized Quality Systems.
Acts as a Center of Expertise for GMP Computerized Quality Systems. Maintains and improves GMP Computerized Quality Systems, ensuring that the JBV Computerized Quality Systems are fit-for-use, compliant, and state-of-the-art technology.
Is responsible for all project aspects of Computerized Quality Systems improvement initiatives and application updates. Project lead for local Quality Systems initiatives.
Is project member in projects initiated by the global Computerized Quality Systems organization and responsible for site/regional implementation and roll out.
Cooperates with the global Computerized Quality Systems team to develop and maintain the J&J standards for regulatory compliance, e.g. on Data Integrity.
Acts as single point of contact for the Global Computerized Quality Systems teams and local business- and end users.
Maintains a relevant network of contacts with Computerized Quality Systems specialists within JBV, JSC and J&J companies, but also with other pharmaceutical companies and professional associations, which will allow him/her to identify best practices for various Computerized Quality Systems.
Is responsible for the consistency in use of the Computerized Quality Systems across processes and departments. Provides support to the end users, resolves issues, and performs troubleshooting.
Defines the skill requirements and develops training programs for Computerized Quality Systems for JBV end users. Ensures that appropriate training is given on these systems.
Ensures that performance, quality and compliance reviews are made, metrics are maintained. Ensures appropriate follow up is done, and information is shared with Site Management.
Ensures that the performance of the system meets regulatory and J&J standards by developing and performing periodic verification on the Computerized Quality Systems.
Ensures good communication with all departments and functional groups within JBV involved in working with Computerized Global Systems. Ensures that JBV management stays adequately informed.
Magnitude & complexity
The focus of the function is to ensure that the core Computerized Quality Systems at JBV meet the state of the art technology and regulatory standards.
The complexity lies also in the fact that jobholder operates in a complex, multi-functional, and multi-site environment, where continuous improvement of the core Computerized Quality Systems is required. The position requires a strong analytical and independent thinking and decision making to find structural, regulatory, and business wise sound solutions. Especially in outside contacts, decisions and actions are made independently and are occasionally reviewed.
If the job is not performed correctly, there is a risk of not identifying or effectively resolving operational compliance or quality issues. This can negatively affect JBV’s compliance or business performance.
Extensive, in depth up-to-date knowledge of computerized quality systems and recent developments in this expertise area is a requirement.
Numerous contacts will be maintained within JBV, and at JSC/J&J. The jobholder is expected to resolve matters effectively even when interests are conflicting. The jobholder is able to negotiate a favorable solution for all parties involved. Outside contacts require tact and diplomacy.
Minimum of Bachelor degree or equivalent in computer science or equivalent; supplemented with additional training or experience during work life.
Pharmaceutical or related industry work experience for 4-6 years, of which a substantial part in Computerized Systems and related functions.
Experience in a complex, multinational work environment/company.
Project management skills and interpersonal skills, engaged in contact with personnel at all levels within the organization.
Written and oral communication skills in English. Dutch is preferable.
Self-starter, planning skills, and ability to prioritize multiple commitments.
Analytical thinking and (technical) problem solving. Lean/Six Sigma experience is desirable.
Pro Active, works independently, takes actions in the absence of specific instruction
Excellent communication and advisory skills, result oriented.
Janssen Biologics (7266)