Indien solliciteer direct u verwijst naar een ongeldig webadres, is de vacature waarschijnlijk inmiddels vervuld.
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Senior manager QA
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.
Het bedrijf / The company
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 successful being proactive and willing to take ownership, collaborate and enthusiastic to work in an innovative and focused environment. As Quality Assurance we take a stand to consistently ensure the delivery of safe, cost effective and high-quality products for the patients in need.
Janssen Vaccines & Prevention BV (8852)
De functie / The role
The senior Manager QA has a critical role in assuring that the Leiden Vaccines site maintains a strong compliance profile and in enabling optimum operational efficiency.
We are looking for an experienced leader that will be part of the site QA leadership team, plays a key role in managing the QA NPD team and collaborate with the site stakeholders to be a trusted business partner. Next to that, this position will provide a unique opportunity to work on new vaccines and will become part of the global network of QA experts.
You will work across multiple projects and teams to manage compliance oversight
throughout our pipeline.
Manages, leads, motivates and empowers the QA NPD team at the Leiden Vaccines Site
Ensure Quality standards are reliably maintained and comply with J&J global guidelines and regulatory expectations
Provide quality and compliance guidance and leadership to the related operational units.
Ensure production and analytical batch records are thoroughly reviewed, deviations in the production and analytical processes as well as product quality complaints are thoroughly investigated
Responsible for the performance and development of the Quality Assurance team.
Manage QA lead times to ensure a timely product disposition and support speed to have products available for the patients.
Use Data Analytics to look at oversight results, trending and Management Reviews to improve efficiency and effectiveness
Drive continuous improvement holistically in the department and for quality topics on the entire site.
Het profiel / Your profile
University degree at a master level in relevant discipline (Biosciences, Pharmacy or Chemistry)
Minimum 10 years of experience in Quality and/or Regulatory Compliance field, preferably in Pharmaceuticals.
Minimum 5 years demonstrated leadership and people development skills
Demonstrated knowledge of Good Manufacturing Practice (GMP) regulations and proven success in implementing and maintaining cGMP compliance
Strong background and knowledge of quality systems management (risk management, product quality management)
Strong decision making and problem-solving competencies
Must be proficient in English (oral and written)
Qualification as QP (or eligible to) would be a plus