Department: Vaccines Product Development Quality
Quality Assurance at Janssen Vaccines & Prevention in Leiden is a fast-developing department.
Janssen Vaccines & Prevention is currently working on a full Vaccine pipeline, developed at our site in Leiden and by external collaborations. The QA Group is responsible for overseeing and supporting the quality systems, projects and facilities. The opportunities and responsibility for the Quality Assurance department to shape and deliver the right quality are key for the success of Janssen Vaccines & Prevention.
The group is forward looking, working on improving processes, being customer focused and supports the need for speed. The team is most successful with employees that are proactive and are willing to take ownership, collaborate and are enthusiastic to work in an innovative and focused environment.
This position will report to the Associate Director Quality providing cross-functional, operational and scientific leadership. The successful candidate acts as interface between different functional teams and interacts with both local and international business partners and key stakeholders. Importantly, the successful candidate can quickly grasp new concepts and content and is able to pro-actively influence both product quality and technical discussions.
The candidate fit for the job is a natural leader and is be able to work effectively and closely together with technical colleagues to align people and processes with quality policies.
Activities will include:
- Collaborates with functional project teams in a matrix environment to drive team accountability for quality deliverables.
- Represents Quality on Global Teams and participates in global initiatives and projects
- Responsible for technical and scientific input within PDQ
- Ensures standard Global Quality processes (risk assessments, technology transfers) are implemented and used at JVL and acts as interface between JVL and Global Quality.
- Responsible to give guidance to QA experts
- Involvement across the portfolio and at all stages of development
- Leads critical site quality issues as well as escalations. Able to de-escalate if appropriate
- Works with the relevant stakeholders to build a pro-active quality culture
- Challenging the teams to be innovative, make it safe to try new approaches and take prudent risks. Coach the team to bounce back quickly from disappointments and learn from mistakes. Drive process improvements across the functions.
- Responsible for managing external Inspections
- Demonstrates business acumen, project management, communication, process management and team performance management.
- Applies scientific and engineering principals for problem solving and advise to the teams
- Review of highly complex scientific and regulatory documentation
- Ensures project deliverables meet business needs (Managing customer critical-to-quality (CTQ) objectives), on time and within budget, in accordance with the program plan and program governance.
- Safeguards effective interfaces and dependencies with other programs and compliance with technical standards.
- Can be a coaching line manager/people leader with a keen eye for personal development
Qualifications for the function of Program Lead QA
- A minimum of PharmD or M.Sc. degree is required. A Ph.D. degree is highly preferred;
- A minimum of 5 years of experience in a Quality or manufacturing as well as R&D environment is required;
- A large span of control, strong scientific background and expertise as proven by track record
- Demonstrated leadership maintaining focus, enthusiasm and momentum and an ability to drive program design plans to completion is required
- Ability to work under pressure in a complex changing environment
- Relationship building, partnering and influencing in a matrixed organization
- Succesfull track record in Pharmaceutical Product Development
- Process-oriented and result-driven
- Customer focused, and good influencing skills
- Business acumen; capable of planning and oversight of project budgets and timelines is required.
- Excellent verbal/written communication as well as organizational skills with the ability to handle multiple projects and timelines with minimal supervision is required.
- Multi-discipline experience preferred.
- Proven track record in leading people and teams to success is a must;
- An effective leader able to manage, empower and develop teams
- Sociable and agile personality with can-do mentality
- Fluent in English
Janssen Vaccines & Prevention BV (8852)