Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
Responsible for performing key Quality tasks in respect of Company products and development projects. Work in the Quality Systems Group, within the Technical Operations department, which oversees, IT Validation projects as well as internal Quality Systems. Reports directly to the Executive Director Quality.
This position is responsible for monitoring and supporting the quality performance of contract vendors for GxP systems. Specific responsibility for providing compliance leadership and direction in computer system validation projects for GMP, GDP, GPvP and GCP areas. This individual receives assignments in the form of goals.
The individual is responsible for, but is not limited to:
Timelines. Facilitate the gathering of business needs, use case and solution criteria as needed
A Degree or Masters level in a science discipline is required, with an excellent understanding of quality assurance. Qualified person status is desirable. Experience with computer system software validation projects in a variety of GxP areas is required. A strong understanding of, and experience in quality management is essential with a proven track record in people management and personnel development.
At least 10 years’ experience gained in finished product pharmaceutical manufacturing including validation activities is required.
Knowledge of QA for Pharmcovigilance, clinical trial data collection and manufacturing operations is desirable. Experience working with outsourced IT solutions is also desirable. An excellent understanding of quality guidelines and regulatory requirements as they apply to the industry is required. Customer orientated with excellent communication skills and the ability to apply pragmatic logic to problem solving and issue resolution is also required.
Jazz Pharmaceuticals is an Equal Opportunity Employer.