Biotech and Agricultural Engineering Management & Business Others Medical and Healthcare
6 - 10 Years
Process and Quality Lead
The Process and Quality Lead (PQL) will contribute to the development of the quality system and training and knowledge management that enables the Janssen Vaccines Clinical Immunology (CI) to operate in a compliant and efficient manner.
The PQL is responsible for collaborating with members of the CI department and other relevant stakeholders in developing, implementing and continuously improving the CI process framework.
The PQL will work on specific projects that contribute to building the quality management system framework and training and knowledge management.
The PQL advises on management of risks and quality issues at Immunolabs and collaborates with CI internal Quality associate.
The PQL participates in inspection readiness activities for clinical trials.
1. The PQL is responsible for leading the development, implementation and management of end-to-end (E2E) process framework within the Janssen Vaccines CI.
2. The PQL will lead or participate in specific working groups related to process development. This includes organization, gathering feedback, organizing review, collating and structuring all information, applying simple process excellence tools to structure and analyze the work.
3. The PQL will work with internal and external stakeholders to fully understand the gaps and opportunities in the current process versus identified business needs or regulatory requirements and ensure that all these are addressed in the newly developed process and that clear dashboards are set up for key stakeholders.
4. The PQL will contribute to the construction and review of Standard Operating Procedures and Training to ensure that these are consistent with the newly developed processes.
5. The PQL drives development of training and knowledge management of the Janssen Vaccines CI department ensuring adequate implementation of processes in alignment with CI internal Quality associate.
6. The PQL can be assigned to clinical trials to assist with risk management, follow up of quality issues, escalations and inspection readiness activities related to outsourced activities in close collaboration with BRQC and Regulatory Compliance. This is done in close collaboration with the PL’s and Department support members.
7. The PQL can be consulted for any process or quality issues and risks related questions for internal and external quality issues.
8. Coaches new CI members on department processes.
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned
DECISION-MAKING AND PROBLEM-SOLVING:
The Process and Quality Lead is a professional function that contributes to the process in the Janssen Vaccines CI organization. Decisions made and problems solved will involve process and training development, working with various stakeholder groups, providing technical and content expertise to teams, reporting and summarizing to cluster leads and management.
Masters degree or BS/BA with minimum of 10 years of previous Pharmaceutical Industry experience or equivalent, with at least 5 years of experience within clinical research.
Extensive experience of the overall drug development process;
Extensive experience in drug development and global project and teamwork
Knowledge of Business Process Management
Knowledge of Risk and Quality Management
Proactive strategic thinker
Strong leader and collaborator
Highly committed to quality
Flexible and persistent
Good conflict handling/negotiation skills
Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks
Excellent communicator, with excellent interpersonal skills and diplomacy
Excellent knowledge of English is required
Proficient in Microsoft Office applications
Able to create win-win situations with internal and external partners
External contacts are frequent and require excellent interpersonal skills and diplomacy
Netherlands-South Holland-Leiden- Organization
Janssen Vaccines & Prevention BV (8852) Job Function
Quality Requisition ID
Open Positions from Johnson & Johnson Family of Companies